Shares of GH Research rose on plans to provide an update on the status of its investigational new drug application for GH001, a therapy for treatment-resistant depression. The stock climbed 19% to $15 ...
US FDA accepts Axsome Therapeutics’ supplemental New Drug Application for AXS-05 to treat Alzheimer’s disease agitation: New York Saturday, January 3, 2026, 12:00 Hrs [IST] Ax ...
FibroBiologics submits IND application with US FDA to initiate clinical trials of CYPS317 in psoriasis patients: Houston Saturday, January 3, 2026, 11:00 Hrs [IST] FibroBiologics ...
FDA grants priority review to Axsome's AXS-05 for treating agitation in Alzheimer's disease with a PDUFA date of April 30, 2026.
Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous ...
RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New ...
Viatris Inc. (NASDAQ:VTRS) also reported that the Japan Pharmaceuticals and Medical Devices Agency (PMDA) accepted its ...
Relacorilant targets glucocorticoid receptor proteins, potentially redefining treatment for platinum-resistant ovarian cancer by inhibiting cancer cell proliferation. Clinical trials show relacorilant ...
The Prescription Drug User Fee Act target guidelines for NDA resubmissions include acknowledgment of acceptance for review ...
Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that it has successfully completed generation and analysis of all key data required to ...
REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Corcept Therapeutics Incorporated (CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, ...
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