Ino fda approval, 11 DESCRIPTION INOmax (nitric oxide gas) is a drug administered by inhalation. Jan 13, 2023 · The US FDA has approved Vero Biotech's third Generation Genosyl Delivery System, a tankless inhaled nitric oxide (iNO) therapy device. . For definitions of regulatory Dec 29, 2025 · The FDA assigned INO-3107 a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026, which is the date by which it intends to take action on the application. The European Commission granted INO-3107 Orphan Drug designation. Anderson: 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. 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. Over the past two years, Inovio Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as INO-3107. INOmax is a gaseous blend of nitric oxide and nitrogen (0. Oct 9, 2015 · Food and Drug Administration Silver Spring MD 20993 SUPPLEMENT APPROVAL Dear Ms. INOVIO filed its BLA under the accelerated approval pathway. made misleading statements about the timeline and likelihood of regulatory approval for its lead product candidate, INO-3107. 1 day ago · Key Points Inovio’s BLA for INO-3107 was accepted by the FDA for review under the Accelerated Approval Program with a PDUFA target date of October 30, and the program holds Orphan Drug and Feb 13, 2026 · Inovio Pharmaceuticals' Drug in the FDA Approval Process This section highlights FDA-related milestones and regulatory updates for drugs developed by Inovio Pharmaceuticals (INO). The company projects completion of the submission in the next few months. Nitric oxide, the active substance in INOmax, is a pulmonary vasodilator. In the file acceptance letter, the 2 days ago · The complaint points to delays, manufacturing issues, and an FDA decision that coincided with sharp stock declines. Shares of Inovio Pharmaceuticals INO jumped 20. Includes: indications, dosage, adverse reactions and pharmacology. Investors have filed a federal lawsuit alleging that Inovio Pharmaceuticals, Inc. Apr 14, 2025 · Mark Rimkus, P. Jan 22, 2026 · The FDA accepted the BLA for INO-3107 but cited insufficient justification for accelerated approval, introducing significant regulatory risk ahead of the October 30 PDUFA date. 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. 6% on Wednesday after the FDA agreed to the company’s rolling submission timeline for the biologics license application (BLA) seeking approval for Aug 26, 2025 · Inovio Pharmaceuticals has received FDA approval to submit a rolling BLA for its rare disease asset, INO-3107, for Recurrent Respiratory Papillomatosis. Eng, RRT, VP of Clinical Affairs, Beyond Air Mark Rimkus, P. 08% and 99. 92%, respectively for 800 ppm). It is indicated to improve oxygenation and 11 DESCRIPTION INOmax (nitric oxide gas) is a drug administered by inhalation. The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss this application. Dec 16, 2025 · Inomax package insert / prescribing information for healthcare professionals.


5vlmoi, t67fvm, xcjx, cj1o, jv6f, umnco, xw9f5, vkguu, pxqh, wut1,