FDA assigns PDUFA target action date in the third quarter of calendar year 2026 with launch expected at the end of September ...
NRx together with Osmind, Inc. conducted an in-person meeting attended by leadership of the FDA Division of Psychiatry Products and leadership of ...
Alume Biosciences delivers positive topline results for three pivotal trials of Bevonescein, advancing toward NDA ...
NEW HAVEN, Conn., Jan. 20, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in ...
This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 ...
FORT LEE, N.J., Jan. 28, 2026 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating ...
FDA PDUFA Goal Date Set for October 17, 2026. RESEARCH TRIANGLE PARK, N.C., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, ...
The MarketWatch News Department was not involved in the creation of this content. SAN DIEGO, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. ("Biosplice"), a clinical-stage ...
Deciphera Pharmaceuticals, a member of Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono"), today announced that the U.S. Food and Drug Administration ...
The FDA has accepted the new drug application (NDA) for tirabrutinib (ONO-4059), a highly selective, irreversible, ...
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