FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026 MINNEAPOLIS, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing ...

Emergent BioSolutions (NYSE:EBS) said the U.S. Food and Drug Administration has approved a supplemental New Drug Application ...

MELBOURNE, Australia and INDIANAPOLIS, Jan. 20, 2026 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, ...

Takeda and Protagonist Therapeutics have submitted a new drug application to the FDA for rusfertide for adults with polycythemia vera.

The FDA has accepted an investigational new drug application for an investigational and proprietary combination therapy to ...

NANJING, China and GAITHERSBURG, Md., Dec. 18, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that the new drug application for Tinengotinib tablets has been ...

Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson's disease spectrum Positive results across all three Phase 3 TEMPO trials ...

Loyal’s application for drug approval is another step closer to potential approval through the FDA Center for Veterinary ...

TAIPEI, Oct. 1, 2025 /PRNewswire/ -- TAHO Pharmaceuticals Ltd. ("TAHO Pharma") today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ...

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 ...

LOR is the first drug candidate with disease-modifying potential for osteoarthritis submitted for approval, demonstrating ...

With a government shutdown now in effect, the U.S. FDA—already shaken up by head count reductions earlier this year—has sought to keep many of its functions running for the foreseeable future. But the ...