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

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

Advicenne (Euronext Growth Paris - FR0013296746 - ALDVI), a pharmaceutical company specializing in the development and marketing of innovative treatments for people suffering from rare kidney diseases ...

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

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 ...

46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...

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 ...

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

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

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 ...

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 ...

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