Pharmaceutical Technology on MSN
Roche receives FDA acceptance for giredestrant combo NDA
The FDA decision is anticipated by 18 December 2026.
Bristol-Myers Squibb (BMS) said today it has withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor—and will retreat from plans to pursue a combination Hepatitis C (HCV ...
SAN FRANCISCO and SUZHOU, China, June 4, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and ...
Zacks Investment Research on MSN
FDA accepts BMY's NDA for iberdomide combo in multiple myeloma
Bristol Myers Squibb BMY announced that the FDA has accepted the new drug application (NDA) for its pipeline candidate, iberdomide, in combination with standard therapies (daratumumab and ...
The NDA submission is based on positive data from pivotal Phase 3 clinical trials in cUTI and cIAI. The primary endpoints were met in the Phase 3 studies. Results of the secondary analyses were ...
FORT LEE, N.J., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the resubmission of a New Drug Application (NDA) to the U.S.
NDA is supported by positive data from two Phase 3 studies and a long-term extension study, demonstrating sustained reduction in heavy menstrual bleeding while maintaining bone health through one year ...
ROCKVILLE, Md. and SUZHOU, China, April 2, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and ...
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