Abbreviated New Drug Application (ANDA) Amendment related to the drug vial for preservative-free ketamine has been reclassified from a Major Amendment to a Minor Amendment. FDA has revised the Generic Drugs User Fee Act (GDUFA) Goal Date to November 10, 2026. WILMINGTON, Del., Sept.
Invention is based on the discovery that ALS may be caused by reactivation of Human Endogenous Retrovirus K (HERV K) Envelope protein (K Env), already coded in the “dark genome” of all people. K Env is found in the spinal fluid of more than 75% of people with ALS and has been shown to produce the
HOPE is the first Interventional Psychiatry network to deploy Zeta Surgical's newly FDA-cleared TMS Robotic System; the HOPE clinical team is completing orientation and training at Zeta Surgical's headquarters in Boston ahead of deployment in HOPE's Florida clinics The Zeta TMS Robotic System's
WILMINGTON, Del., Sept. 08, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals" or the "Company"), a clinical-stage biopharmaceutical company, today announced that the management team will participate in three upcoming investor conferences in September 2026.
Key recent and second quarter highlights include: Completed first-cycle FDA review of the Company’s ANDA for preservative-free ketamine with no drug-related major deficiencies. The sole remaining item, a manufacturer's attestation on the vial, has been submitted to FDA.
Conference Call 8:30 a.m. ET, Monday, August 10, 2026 MIAMI, Aug. 07, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will host a conference call and Q&A session on Monday,
FDA identified no major deficiencies related to the ketamine drug product, ingredients, proposed labeling, CMC, or other drug-related review matters. Remaining item relates to manufacturer certification for a luer lock vial already used in three FDA-approved ANDA products with 11.9 million units
WILMINGTON, Del., June 25, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx” or the “Company”) today issued the following statement in response to recent public claims made by Kadima Neuropsychiatry Institute (“Kadima”). Kadima issued a public statement on June 24, 2026
First Zeta-navigated TMS treatments have begun at HOPE Therapeutics clinics in West Palm Beach and Sarasota, Florida, marking the transition from research deployment to active patient care AI-powered, sub-millimetric image guidance is now being applied in HOPE's outpatient TMS workflows for