FDA Grants Accelerated Approval to Etcamah (camizestrant) in Combination with a CDK4/6 Inhibitor for the Treatment of Advanced HR-Positive Breast Cancer
September 4, 2026 -- AstraZeneca’s Etcamah (camizestrant) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (abemaciclib, palbociclib or ribociclib) has been approved in the US for the
FDA Approves Zanvastro (zilganersen) for the Treatment of Alexander Disease
CARLSBAD, Calif. -- (BUSINESS WIRE) -- September 3, 2026 -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has approved Zanvastro (zilganer
FDA Approves Mimrylo (rusfertide) for the Treatment of Polycythemia Vera
OSAKA, Japan and CAMBRIDGE, Massachusetts, August 28, 2026 -- Takeda (TSE:4502/NYSE:TAK) announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)* for Mimrylo (rusf
FDA Approves Bixlenvo (bictegravir and lenacapavir) for the Treatment of HIV in Adults Who Are Virologically Suppressed
FOSTER CITY, Calif.--(BUSINESS WIRE) -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), t
FDA Approves Lisraya (brepocitinib) for the Treatment of Adults with Dermatomyositis
BASEL, Switzerland and LONDON and NEW YORK, August 27, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced that the U.S. Food and Drug Administration (FDA) has approved Lisraya (brepocitin
FDA Approves Rasonque (daraxonrasib), the First Broad RAS-Targeted Medicine in Metastatic Pancreatic Cancer
REDWOOD CITY, Calif., Aug. 26, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a global commercial-stage oncology company dedicated to discovering, developing and delivering innova
FDA Approves Pasatru (garetosmab-grts) for the Treatment of Fibrodysplasia Ossificans Progressiva
TARRYTOWN, N.Y., August 19, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted approval for Pasatru™ (garet
FDA Grants Accelerated Approval for Genglycos (pariglasgene brecaparvovec-opnr) Gene Therapy for the Treatment of Glycogen Storage Disease Type Ia
NOVATO, Calif., August 19, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Geng
FDA Grants Accelerated Approval to Zenbexus (iberdomide) in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone for the Treatment of Multiple Myeloma
PRINCETON, N.J. -- (BUSINESS WIRE) -- August 13, 2026 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Zenbexus (iberdomide) in combina
FDA Approves Tauklarify (florquinitau F 18 injection), an F18-Labeled Tau PET Imaging Agent for Alzheimer’s Disease
BEDFORD, Mass., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians
FDA Grants Accelerated Approval to Tudriqev (vusolimogene oderparepvec-wtpg) in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma
WOBURN, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today ann
FDA Approves Orzeyful (oveporexton) to Treat the Underlying Cause of Narcolepsy Type 1
OSAKA, Japan and CAMBRIDGE, Massachusetts, August 5, 2026 -- Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) approved Orzeyful™ (oveporexton), an oral orexin rece
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