The FDA accepted a new drug application for a single inhaler that contains beclomethasone dipropionate, formoterol fumarate ...

The FDA has accepted for review the NDA for Chiesi’s single inhaler triple therapy for the maintenance treatment of asthma in adults.

Disc is seeking accelerated approval and priority review of its NDA submissionFDA decision to accept and file the NDA for review occurs within 60 ...

The U.S. Food and Drug Administration on Thursday announced the names of nine products, under a new fast-track review process ...

Relacorilant targets glucocorticoid receptor proteins, potentially redefining treatment for platinum-resistant ovarian cancer by inhibiting cancer cell proliferation. Clinical trials show relacorilant ...

Pharming Group has announced that the US Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for leniolisib in paediatric patients.

October 15, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), reports that an analyst research report was ...

Praxis Precision Medicines PRAX stock surged after Phase 3 trials for its essential tremor drug met endpoints, prompting TD ...

KANSAS CITY, Kan., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform ...

A gene therapy from Regeneron, a pancreatic cancer medicine from Revolution Medicines and a porphyria drug from Disc Medicine ...

NMPA’s response is based on the Phase 3 DRAGON interim analysis resultsTopline final data expected in Q4 2025 SAN DIEGO, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a ...

CHENGDU, China, Sept. 22, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that a new drug application (NDA) for the Company's small molecule rearranged ...