Ino fda approval Eng, RRT (Beyond Air): In the United States, inhaled nitric oxide (iNO) is FDA-approved for the treatment of term and near-term neonates (≥34 weeks gestation) with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. 15, 2020 /PRNewswire/ — VERO Biotech LLC, an Atlanta, Georgia-based biotechnology Aug 19, 2024 · The FDA clearance is a testament to VivaChek Biotech’s dedication to providing superior healthcare solutions globally. 6% on Wednesday after the FDA agreed to the company’s rolling submission timeline for the biologics license application (BLA) seeking approval for Jan 17, 2023 · INOmax is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. Oct 21, 2024 · The FDA granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation, and advised INOVIO that it could submit its BLA under the accelerated approval program using data from its already completed Phase 1/2 trial. (NASDAQ: INO) has announced that it has received FDA approval to begin a rolling submission of its Biologics License Application (BLA) for INO-3107, an investigational DNA medicine designed to treat Recurrent Respiratory Papillomatosis (RRP) in adults. iNO is approved for specific indications, such as the treatment of term and near-term infants with hypoxic respiratory failure May 13, 2025 · With INO-3107's Breakthrough Therapy designation and planned request for priority review, INOVIO could potentially receive an approval decision by mid-2026. Aug 10, 2023 · Inovio is making its third round of layoffs in 13 months. It is indicated to improve oxygenation and Oct 9, 2015 · Please refer to your Supplemental New Drug Applications (sNDAs) dated December 8, 2014 (S 016) and December 11, 2014 (S-017) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for INOmax (nitric oxide) for inhalation. The second feature is a simpler The approval was based on data from INO-VATE ALL (NCT01564784), a randomized (1:1), open label, international, multicenter study in 326 patients with Philadelphia chromosome-negative or Jan 9, 2023 · Unlike tank-based systems, GENOSYL DS generates iNO at the bedside using a small disposable cassette. , INOmax is one form of INO that has FDA approval for the treatment of hypoxic respiratory failure in neonates). Numerous publications have Mar 6, 2024 · The FDA has approved inotuzumab ozogamicin for pediatric patients with relapsed/refractory CD22-positive B-cell precursor acute lymphoblastic leukemia. Dec 22, 2020 · The GENOSYL® DS facilitates patient treatment in interhospital and intrahospital transport, and in diverse diagnostic and imaging settings, representing the broadest FDA approved label in the industry allowing use in the Acute-care Setting including MRI, Ground, Fixed Wing and Rotary Transport. The company's primary focus is on the ongoing progress of strategic priorities, with a continued emphasis on surgery reduction as demonstrated by the 3107 data showing sustained results. Inovio expects to finalize th… Jan 3, 2024 · Inovio (INO) is aiming to submit a Biologics License Application for its drug INO-3107 to the FDA under the accelerated approval program. While the formal Sep 29, 2022 · Mallinckrodt plc reports the submission of a 510 (k) premarket notification application to the US FDA for an investigational inhaled nitric oxide delivery system for INOmax (nitric oxide) gas, for inhalation. Regulatory Status The Food and Drug Administration (FDA) approved the INOmax iNO delivery system in 1999 for use in intubated infants in the neonatal intensive care unit with hypoxemic respiratory failure (FDA 1999). Despite the potential approval of Papzimeos, Inovio remains optimistic about its own pipeline, particularly INO-3107. INO-3112 is a DNA medicine candidate containing a DNA plasmid encoding HPV-16/-18 E6 and E7 antigens combined with another DNA plasmid encoding IL-12 as an immune activator. Russo@VERO-biotech. 1 to 0. Feb 2, 2023 · VERO Biotech Inc. S. Atlanta-based Vero Biotech designed Genosyl for inhaled nitric oxide (iNO) delivery. Ongoing Research May 13, 2025 · Inovio management emphasized steady progress toward BLA submission for INO-3107, with milestones on track for a potential FDA filing acceptance by year-end and a possible mid-2026 PDUFA date. Sep 30, 2024 · Inovio's BLA filing delay impacts market confidence. Facing a long path to approval, the biotech has stopped its cervical lesion program to focus on its most promising, closest-to-market Jul 29, 2020 · This orphan drug designation from the FDA qualifies INO-3107 for various development incentives, including a tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, research grant awarded by the FDA, and most importantly, 7 years of U. Jan 3, 2024 · The FDA previously granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation, and advised INOVIO that it could submit its BLA under the accelerated approval program using data Jul 7, 2025 · Precigen's future hinges on the FDA's approval of PRGN-2012, with a pivotal decision expected August 27, 2025. DNA therapies deliver a drug directly to a patient’s cells to improve the body’s ability to fight a disease. The first is faster dosing, using an adaptive sensor and automated cassette action to reach the needed dose sooner. Mar 6, 2024 · On March 6, 2024, the Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell Aug 12, 2025 · On track to submit Biologics License Application (BLA) for INO-3107 in 2H25, with the goal of file acceptance by year end Completed design verification (DV) testing of CELLECTRA® 5PSP device required for BLA submission and requested rolling submission from US Food and Drug Administration (FDA) Continuing to advance commercial preparations for potential launch of INO-3107 in 2026 if approved Nov 9, 2021 · FDA Lifts Partial Clinical Hold on INNOVATE Phase 3 Segment INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to help protect people from infectious diseases and treat cancer and HPV-associated diseases, today announced that the U. , a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of its innovative second generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use with rebreathing anesthesia in the operating room setting. FDA Lifts Partial Clinical Hold on INNOVATE Phase 3 Segment Aug 24, 2025 · Precigen’s Papzimeos is the first FDA-approved drug for the rare disease recurrent respiratory papillomatosis, or RRP. com December 20, 2019, – VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives May 20, 2020 · Abstract Upon the FDA approval for inhaled nitric oxide (iNO) in 1999 to treat persistent pulmonary hypertension in neonates, iNO has proven to be a beneficial therapeutic in multiple diseases. InO is an antibody-drug conjugate that works by delivering chemotherapy directly to cancer cells. Oct 10, 2023 · INOVIO today announced that it has received feedback from the U. INO-3107 received Orphan Drug designation from the European Commission in May 2023 and from the FDA in 2020. FDA approved Precigen’s zopapogene imadenovec-drba, marking a significant advancement in RRP treatment options. Jan 3, 2024 · The FDA previously granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation, and advised INOVIO that it could submit its BLA under the accelerated approval program using data Aug 9, 2013 · Inhaled nitric oxide (iNO) therapy, the only FDA-approved therapy for persistent pulmonary hypertension of the newborn, is expensive and negatively impacts the Respiratory Care Department’s budget. Nitric Oxide Delivery Systems INOmax must be administered using a calibrated, FDA-cleared Nitric Oxide Delivery System (NODS). If the agency grants priority review, a decision could follow around mid-2026. INO is approved by the United States Food and Drug Administration (FDA) for the treatment of term and near-term neonates with … Feb 3, 2023 · The Genosyl system. , a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, today announced FDA approval of its innovative second generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use with rebreathing anesthesia in the operating room setting. The safety and efficacy of the investigational inhaled nitric oxide delivery system has not been evaluated by the FDA. PRGN-2012 shows strong efficacy and safety, potentially transforming the treatment of Dec 30, 2023 · The FDA has cleared the INOmax Evolve DS for the delivery of INOmax nitric oxide gas for inhalation, according to Mallinckrodt plc. This achievement not only strengthens VivaChek Biotech’s standing as a leader in the medical device industry but also sets the stage for future advancements in blood glucose monitoring technology. Please refer to your Supplemental New Drug Application (sNDA) dated June 25, 2012, submitted under section 505(b)/pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for INOmax (nitric oxide) for inhalation. Dec 23, 1999 · Note: Documents in PDF format require the Adobe Acrobat Reader®. These studies led to FDA approval for the use of iNO as a pulmonary vasodilator in term and near-term (> 34 weeks’ gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. INOVIO is conducting ongoing market research with physicians, patients and payors to support its commercial readiness plans. Aug 27, 2025 · INO-3107's rolling BLA progresses after FDA support despite delays. Commercial preparations are currently underway for a potential 2026 launch of INO-3107, pending FDA approval. Nov 7, 2023 · If approved, INO-3107 could be the first non-surgical treatment available for recurrent respiratory papillomatosis, which is caused by infection with two types of human papillomavirus (HPV). May 11, 2024 · Inotuzumab ozogamicin (INO) is an anti-CD22 antibody-drug conjugate that was first evaluated in B-cell lymphomas but was subsequently shown to be highly effective in acute lymphoblastic leukemia (ALL). Jan 3, 2024 · The FDA previously granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation, and advised INOVIO that it could submit its BLA under the accelerated approval program using data from its already completed Phase 1/2 trial. A biosimilar is highly similar to, and has no clinically meaningful differences in safety, purity, and potency (safety and effectiveness) from, an existing FDA-approved reference product. Jan 16, 2025 · In line with the FDA's mission, the INO's primary focus is ensuring the safety, quality, and effectiveness of food and medical products exported to the United States. Jan 10, 2023 · Vero Biotech announced that it received FDA approval for its latest-generation tankless inhaled nitric oxide (iNO) delivery system. Jan 9, 2023 · ATLANTA, Jan. Jan 11, 2023 · VERO Biotech has received the US Food and Drug AdiFDA approval for new-generation tankless inhaled nitric oxide (iNO) delivery system (DS). While this immunotherapy carries blockbuster expectations, Precigen’s Inhaled nitric oxide should be administered using FDA-approved devices (e. We aim to review applications of iNO that have modeled its protective and therapeutic attributes, as well as highlight preliminary studies that could allude to future avenues of use. When given via the inhaled route it is a selective pulmonary vasodilator. Jan 3, 2020 · The FDA has approved the Genosyl inhaled nitric oxide (iNO) gas delivery system, according to Vero Biotech LLC. May 7, 2025 · The FDA previously granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation and has advised INOVIO that it can submit a biologics license application under the FDA's accelerated approval program using data from INOVIO's already completed Phase 1/2 trial. Nov 3, 2025 · The FDA has granted INO-3107 both Orphan Drug and Breakthrough Therapy designations and previously advised INOVIO that it could submit a BLA under the FDA's accelerated approval program using data Dec 15, 2024 · Inomax package insert / prescribing information for healthcare professionals. Aug 11, 2025 · The FDA has granted INO-3107 both Orphan Drug and Breakthrough Therapy designations and has advised INOVIO that it can submit a biologics license application under the FDA's accelerated approval program using data from INOVIO's completed Phase 1/2 trial. INOmax is a vasodilator, which, in conjunction with ventilatory support and Dec 3, 2024 · The FDA previously granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation and has advised INOVIO that it can submit a biologics license application under the FDA's accelerated approval program using data from INOVIO's already completed Phase 1/2 trial. INO-4201 for Ebola Aug 14, 2025 · The approval by the FDA underscores the drug's safety and efficacy, positioning it as a strong candidate for market entry. In 1991, iNO as a selective pulmonary vasodilator was recommend in models of PH (5). 6% on Wednesday after the FDA agreed to the company’s rolling submission timeline for the biologics license application (BLA) seeking approval for Aug 28, 2025 · Inovio stock surges 21% after the FDA gives green light to begin a rolling BLA for its RRP drug INO-3107, with plans to seek priority review. Inovio Pharmaceuticals (NASDAQ:INO) has been closely monitoring these developments. INO is approved by the United States Food and Drug Administration (FDA) for the treatment of term and near-term neonates with hypoxemic respiratory failure associated with clinical or echocardiographic evidence of Oct 10, 2023 · INO-3107 was designated a Breakthrough Therapy by the FDA in September 2023. 2, 2023 /PRNewswire/ — VERO Biotech Inc. iNO has been demonstrated to effectively decrease pulmonary artery pressure and improve oxygenation, while decreasing extracorporeal life support use in hypoxic newborns affected by persistent pulmonary Nov 3, 2025 · The FDA has granted INO-3107 both Orphan Drug and Breakthrough Therapy designations and previously advised INOVIO that it could submit a BLA under the FDA's accelerated approval program using data from INOVIO's completed Phase 1/2 trial. INOmax has been administered with dopamine, dobutamine, steroids, surfactant, and high-frequency ventilation. Numerous Feb 3, 2023 · Vero Biotech Inc announced FDA approval of its second-generation Genosyl tankless iNO delivery system for rebreathing anesthesia. While the Inhaled nitric oxide (iNO) treatment for individuals outside of the Infancy age group is experimental or investigational, due to lack of Food and Drug Administration (FDA) approved indications. Numerous publications have Jan 9, 2023 · VERO Biotech Inc. g. Infants with severe respiratory disease frequently require magnetic resonance imaging (MRI) scans for … Aug 14, 2024 · Plymouth Meeting-based Inovio is delaying plans to seek Food and Drug Administration approval for its experimental DNA medicine as a treatment for recurrent respiratory papillomatosis before the end of the year due to a recent setback, writes John George for the Philadelphia Business Journal. PRGN-2012 shows strong efficacy and safety, potentially transforming the treatment of Jan 3, 2024 · The FDA previously granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation, and advised INOVIO that it could submit its BLA under the accelerated approval program using data Jul 7, 2025 · Precigen's future hinges on the FDA's approval of PRGN-2012, with a pivotal decision expected August 27, 2025. May 20, 2020 · Upon the FDA approval for inhaled nitric oxide (iNO) in 1999 to treat persistent pulmonary hypertension in neonates, iNO has proven to be a beneficial therapeutic in multiple diseases. , a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, today announced FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery system. In adult patients with pulmonary arterial hypertension (PAH), inhaled NO has an established role in acute pulmonary vasoreactivity testing during right heart catheterization Jan 9, 2023 · The US Food and Drug Administration (FDA) has approved the third generation of the tankless Genosyl (nitric oxide; VERO Biotech Inc) system for neonatal intensive care. Currently, iNO is widespread in the daily clinical practice for kinds of cardiopulmonary disorders. In 1999, the FDA approved iNO for neonatal patients (>34 weeks gestation) in hypoxic respiratory failure patients with PH (6). Nov 13, 2024 · The FDA previously granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation and has advised INOVIO that it can submit a biologics license application under the FDA's accelerated approval program using data from INOVIO's already completed Phase 1/2 trial. Priority Review may expedite approval by late 2025. Several clinical trials are investigating InO in combination with low-intensity chemotherapy or other anti-ALL-targeted therapies in the salvage and … Oct 6, 2025 · Key Takeaways INO-3107 immunotherapy reduced surgical interventions in RRP, with a mean decrease from 4. , a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, today announced FDA approval of its innovative second generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use with rebreathing anesthesia in the operating Jan 9, 2023 · VERO Biotech received FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery system. Jul 9, 2025 · Inovio Pharmaceuticals (NASDAQ:INO) stock rises as Piper Sandler issues new Overweight rating, citing FDA approval for its lead drug INO-3107 next year. . Food and Drug Administration (FDA) that data from its completed Phase 1/2 trial of INO-3107 for the treatment of RRP could support INOVIO's submission of a BLA for review under the FDA's accelerated approval program. Jan 9, 2025 · INOVIO's INO-3107 demonstrates remarkable durability in RRP treatment with 50% achieving surgery-free status. Market research suggests INO-3107 could become the preferred treatment option if approved, representing a potential first-in-class non-surgical therapeutic for this devastating disease. Inhaled NO is currently approved for treatment of persistent pulmonary hypertension of the newborn (PPHN). Genosyl has 3 new features to provide benefits for patients and providers. Abstract Inotuzumab ozogamicin (INO) is an anti-CD22 antibody-drug conjugate that was first evaluated in B-cell lymphomas but was subsequently shown to be highly effective in acute lymphoblastic leukemia (ALL). 1 Here’s how it works: Apr 10, 2025 · Overview of Inotuzumab Ozogamicin (InO) Inotuzumab ozogamicin (InO), also known as BESPONSA (Pfizer), is an FDA-approved medication used to treat relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) in adults. Food and Drug Administration (FDA) approved inotuzumab ozogamicin, an anti-CD22 monoclonal antibody, for adults with relapsed/refractory B-cell precursor acute lymphocytic leukemia (ALL). Aug 26, 2025 · INOVIO Pharmaceuticals, Inc. This Inhaled nitric oxide (INO) is a colorless, odorless gas that is also a potent pulmonary vasodilator. The previously cleared VivaChekTM Ino Plus blood glucose meter (k173140) has been modified to add a ketone measurement function in this submission. Genosyl is a tankless, portable iNO system that eliminates the need for large nitric oxide tanks. There are various FDA-cleared NODS; refer to the NODS labeling to determine which NODS to use with this drug product and for needed information on training and technical support for users of this drug product with the NODS. The European Commission granted INO-3107 Orphan Drug designation. In June 2022, the first nitric oxide generator and delivery system, LungFit PH, was approved by the FDA as a medical device. This eliminates the need for hospitals to manage large, cumbersome tanks and helps to simplify Oct 1, 2025 · In 1999, the U. The cost has historically restricted its use to large university centers and children’s hospitals. Jun 24, 2020 · While this was associated with symptomatic improvement, the process is laborious and the data are sparse; further research on and clinical use of long-term INO have been stymied by the high cost and lack of insurance coverage for off-label applications after FDA approval for PPHN, but interest has resurged recently. Jan 7, 2021 · Inhaled nitric oxide (iNO) is a pulmonary vasodilator approved for use to improve lung function in neonates >34 weeks' gestational age with hypoxic respiratory failure and pulmonary hypertension. Read more here. Approximately 20 subjects will receive INO-3107 via standard needle, followed by approximately 10 subjects who will receive INO-3107 via the Side Port Needle. INOVIO has also received CE marking for its CELLECTRA® delivery device in the EU, facilitating commercialization in the region [1]. 9 surgeries over two years. Sep 7, 2023 · INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the U. Shares of Inovio Pharmaceuticals INO jumped 20. The drug's approval was based on results from the randomized, phase III INO-VATE 1022 trial, which included 326 patients who had previously received one or two ALL treatments. 1 Inhaled nitric oxide (iNO) was the first selective pulmonary vasodilator and was FDA-approved as INOmax in 1999 10,13 INOmax continues to be the market leader* of iNO delivery for HRF over 25 years later 14 *Based on February 2024 market share data. Nov 7, 2025 · INOVIO expects the FDA to accept the BLA by the end of 2025. Company advances toward BLA submission with strong trial results and $84M cash. Sep 12, 2024 · INO staff participated in panel discussions and worked with the conference organizers to develop presentations to educate industry on how the FDA views its distinctly different drug and dietary Aug 2, 2024 · Inotuzumab ozogamicin (InO) is an antibody-drug conjugate approved for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). Feb 2, 2023 · Second Generation GENOSYL® DS is the first and only Inhaled Nitric Oxide delivery system that is FDA-approved for rebreathing anesthesia, which provides a significant advantage in patient comfort May 10, 2024 · On April 30, NBIX announced that the FDA approved INGREZZA® SPRINKLE capsules, introducing a new oral granules version of INGREZZA® capsules prescribed for treating adults with tardive dyskinesia and chorea linked to Huntington's disease. Nov 3, 2025 · The FDA has granted INO-3107 both Orphan Drug and Breakthrough Therapy designations and previously advised INOVIO that it could submit a BLA under the FDA's accelerated approval program using data from INOVIO's completed Phase 1/2 trial. Approval of INO-3107 would mark INOVIO’s first commercial product and the first DNA-based medicine available in the United States. Sep 7, 2023 · INOVIO plans to initiate a pivotal trial of INO-3107 in the first quarter of 2024, subject to FDA clearance. Includes: indications, dosage, adverse reactions and pharmacology. Jan 5, 2024 · This FDA filing will be the first time in its 24-year history that Inovio sought FDA approval for a DNA medicine it developed. Nov 9, 2021 · INOVIO Receives U. Oct 9, 2024 · Subsequent FDA approvals have expanded coverage to include multiple respiratory support devices, including high-flow nasal cannula and CPAP device and transport ventilators (1FDA 2020), Subsequent FDA approval has also incorporated neonatal transport as a secondary targeted clinical setting (1FDA 2020). Dec 5, 2024 · INO Therapeutics LLC: INOmax is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory INO-3107 will be administered IM followed by EP in subjects at Day 0, Weeks 3, 6, and 9. Health professional staff that administers nitric oxide therapy have access to supplier-provided 24 hour/365 days per year technical support on the delivery Regulatory Status The Food and Drug Administration (FDA) approved the INOmax iNO delivery system in 1999 for use in intubated infants in the neonatal intensive care unit with hypoxemic respiratory failure (FDA 1999). Mar 18, 2025 · Advanced development plans for a Phase 2 trial for INO-4201 as a potential booster to ERVEBO® (rVSV-ZEBOV), including gaining alignment with FDA on the trial's protocol and path to potential Aug 28, 2025 · Shares of Inovio Pharmaceuticals INO jumped 20. The goal Aug 28, 2025 · Like Inovio’s INO-3107, Papzimeos also enjoys the FDA’s breakthrough therapy and orphan drug designation for the RRP indication. INO improved response rates and survival in a randomized study in adults with relapsed/refractory B-cell ALL, leading to its regulatory approval in the United States in 2017. Aug 17, 2017 · The U. Patients were Mar 6, 2024 · The FDA has granted approval to inotuzumab ozogamicin (Besponsa) as a treatment for pediatric patients who are 1 year or older diagnosed with relapsed/refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL), according to a press release from the agency. The FDA's Breakthrough Therapy designation is a process designed to expedite the development and review of promising drugs that would treat a serious Mar 2, 2023 · Under the new design, the FDA no longer considered REVEAL2 to be pivotal, shutting down Inovio’s plans of filing for approval based on the data this year. The RRP-002 study reported no serious adverse events, supporting the long-term safety of INO-3107. May 13, 2025 · FDA has previously awarded breakthrough therapy designation for INO-3107 and INOVIO plans to request priority review of its BLA, which if granted would allow for an FDA approval decision (PDUFA date) in mid-2026. The approval of new therapies underscores Aug 26, 2025 · The FDA has granted INO-3107 both Orphan Drug and Breakthrough Therapy designations, enabling the company to submit its BLA under the FDA's accelerated approval program. Feb 12, 2025 · The FDA previously granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation and has advised INOVIO that it can submit a biologics license application under the FDA's accelerated approval program using data from INOVIO's already completed Phase 1/2 trial. Jan 13, 2023 · The US FDA has approved Vero Biotech's third Generation Genosyl Delivery System, a tankless inhaled nitric oxide (iNO) therapy device. ATLANTA, Dec. Dec 20, 2019 · The GENOSYL® inhaled nitric oxide approval represents the first and only FDA-approved tankless delivery system and is an important new development in the clinical application of inhaled nitric oxide. Abstract Inhaled nitric oxide (iNO) acts as a selective pulmonary vasodilator and it is currently approved by the FDA for the treatment of persistent pulmonary hypertension of the newborn. Inhaled nitric oxide (INO) is a colorless, odorless gas that is also a potent pulmonary vasodilator. market exclusivity upon approval for the treatment of RRP. 9, 2023 /PRNewswire/ — VERO Biotech Inc. Dec 14, 2021 · INOVIO is also evaluating INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2/3 clinical trial; the Phase 3 segment of which has received regulatory approvals to proceed in Colombia, Mexico, Brazil, Philippines, India, Thailand, and the United States. FOR IMMEDIATE RELASE Contact: Ray Russo (908) 313-7172 Ray. Feb 2, 2023 · ATLANTA, Feb. Aug 26, 2025 · The FDA has granted INO-3107 both Orphan Drug and Breakthrough Therapy designations and has advised INOVIO that it can submit a BLA under the FDA's accelerated approval program using data from INOVIO's completed Phase 1/2 trial. The Shares of Inovio Pharmaceuticals INO jumped 20. INOmax is a vasodilator, which, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (> 34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation (1. The approval and regulation of iNO as a therapeutic agent falls under the jurisdiction of regulatory agencies such as the FDA in the United States and the European Medicines Agency (EMA) in the European Union. 6% on Wednesday after the FDA agreed to the company’s rolling submission timeline for the biologics license application (BLA) seeking approval for INO-3107 in adult patients with recurrent respiratory papillomatosis (RRP). Food and Drug Administration (FDA) provided authorization to proceed for INOVIO's INNOVATE Phase 3 Management plans to seek accelerated approval for the drug in the RRP indication. Exclusive Plasma Pulse Technology™ The first and only FDA approved system that generates iNO from room air. Learn more about INO stock and the challenges facing this biotech company. In December 2024, Precigen completed submission of the rolling BLA for Papzimeos to treat RRP, under the FDA’s accelerated approval pathway. 1 Mar 6, 2024 · LOQTORZI is a PD-1 inhibitor recently approved by the FDA for the treatment of recurrent locally advanced/metastatic nasopharyngeal carcinoma. Principle of Operation: Aug 13, 2025 · Inovio Pharmaceuticals aims to submit a Biologics License Application (BLA) for INO-3107 by year-end 2025 and target FDA file acceptance by the same time. Aug 28, 2025 · Commercial preparations are currently underway for a potential 2026 launch of INO-3107, pending FDA approval. INOVIO’s INO-3107, a potential treatment for Recurrent Respiratory Papillomatosis (RRP), has received FDA Breakthrough Therapy designation. Eng, RRT, VP of Clinical Affairs, Beyond Air Mark Rimkus, P. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for INO-3107 as a potential treatment for patients with Recurrent Respiratory Papillomatosis Oct 10, 2023 · INOVIO Receives FDA Feedback that Data from Completed Phase 1/2 Trial of INO-3107 Can Be Used to Submit a BLA Under Accelerated Approval Program REVIEW SUMMARY: INOmax is an inhaled nitric oxide product produced by INO Therapeutics, initially approved in 1999. Feb 6, 2023 · ATLANTA, Feb. , a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, today announced FDA approval of its innovative second generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use with rebreathing anesthesia in the operating Apr 14, 2025 · Mark Rimkus, P. Mar 18, 2025 · Advanced development plans for a Phase 2 trial for INO-4201 as a potential booster to ERVEBO® (rVSV-ZEBOV), including gaining alignment with FDA on the trial's protocol and path to potential approval. INO-3112 is a DNA medicine candidate targeting HPV-16/18 combined with a DNA plasmid for IL-12 as an immune activator. LOQTORZI is an FDA-approved PD-1 inhibitor approved for the treatment of recurrent locally advanced/metastatic nasopharyngeal carcinoma. The European Commission has also granted INO-3107 Orphan Drug designation. Food and Drug Administration (FDA) approved INOmax ® (nitric oxide for inhalation) (INO Therapeutics, Hazelwood, MO) for use, in conjunction with ventilatory support and other appropriate agents, in the treatment of term and near-term (greater than 34 weeks) neonates with hypoxic respiratory failure associated with clinical Training in Administration The user of INOmax and Nitric Oxide Delivery Systems must satisfactorily complete a comprehensive periodic training program for health care professionals provided by the delivery system and drug manufacturers. In 2025, the company anticipates finalizing the trial protocols and seeking funding to support trial activities. Aug 17, 2017 · The approval was based on results from the Phase 3 INO-VATE ALL trial, a randomized, open-label, international, multicenter study evaluating the safety and efficacy of BESPONSA compared with Investigator’s choice of chemotherapy in 326 adult patients with relapsed or refractory B-cell ALL. Nov 11, 2024 · INTRODUCTION Nitric oxide (NO) is a naturally occurring vasodilator produced by vascular endothelial cells. Click here to read my analysis. 7 DRUG INTERACTIONS No formal drug-interaction studies have been performed, and a clinically significant interaction with other medications used in the treatment of hypoxic respiratory failure cannot be excluded based on the available data. The INOmax Evolve DS is the company’s next-generation nitric oxide delivery system with a fully integrated design that includes a primary delivery system, a monitoring system, an electronic blender, automated backup delivery, mini-cylinders, and more. INOmax (nitric oxide) gas, for inhalation, is an FDA-approved Nitric Oxide Delivery Systems INOmax must be administered using a calibrated, FDA-cleared Nitric Oxide Delivery System (NODS). 1). [Image from the Vero Biotech website] Vero Biotech announced that the FDA approved its second-generation Genosyl system for use with rebreathing anesthesia in the operating room setting. This “Prior Approval” supplemental new drug application provides for labeling revised as follows: GeNOsyl was approved via a new drug application (NDA) and must only be administered using a calibrated Genosyl Delivery System (a tankless, portable INO system that eliminates the need for large nitric oxide tanks). FDA Authorization to Proceed with INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800, in the U. Feb 12, 2025 · The FDA previously granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation and has advised INOVIO that it can submit a biologics license application under the FDA's Sep 18, 2017 · Inotuzumab (Besponsa®) has been approved by FDA for some adults with B-cell acute lymphoblastic leukemia (ALL) that has returned or doesn’t respond to chemotherapy. Feb 12, 2025 · The FDA previously granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation and has advised INOVIO that it can submit a biologics license application under the FDA's Mar 7, 2024 · VERO Biotech Inc.
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