Following the adoption of a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)...
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvem...
Kite, a Gilead Company (Nasdaq: GILD), announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Yescarta® (axica...
Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned a...
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced additional positive Phase 3 results in adolescents for it...
MediBeacon Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the MediBeacon® TGFR for the assessment of kidney fu...
Kindeva Drug Delivery’s global health security division, Meridian Medical Technologies, LLC, secured a contract valued at up to $129 million t...
OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, ...
Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Omvoh® (mirikizumab-mrkz) for...
Incyte (Nasdaq:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo™...
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality me...
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced positive results from the Phase 3 C-POST trial, which demonstrated that adjuvant treatment wi...
Bayer announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for KERENDIA® (finerenone...
-Revvity, Inc. announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN’s automated chemilu...
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