WILMINGTON, Del., June 5, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced the transmission of its Abbreviated New Drug ...
FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review.
Waiver exempts NRx from paying a $4.3 million New Drug Application filing fee under the Prescription Drug User Fee Act (PDUFA) Company is on track for Q2 2025 completion of NDA filing and PDUFA date ...
Granting of Suitability Petition enables re-filing of Abbreviated New Drug Application (ANDA) for NRx’s patent-pending preservative-free ketamine product NEW YORK, NY / ACCESS Newswire / September 24, ...
In June 2025 NRx filed an Abbreviated New Drug Application with the FDA for a preservative-free preparation of ketamine, demonstrating support for 3 year room temperature stability and sterility. NRx ...
Toronto, Ontario--(Newsfile Corp. - March 3, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty pharmaceutical company, is pleased to announce ...
Nrx Pharmaceuticals Announces US Food And Drug Administration (FDA) Receipt Of ANDA For KETAFREETM, A Preservative-Free IV Ketamine. <li /> FDA has determined that NRx's Abbreviated New Drug ...
Granting of Suitability Petition enables re-filing of Abbreviated New Drug Application (ANDA) for NRx's patent-pending preservative-free ketamine product NEW YORK, NY / ACCESS Newswire / September 24, ...
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