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
FDA Approves mFLUSIVA (influenza vaccine, mRNA) for the Prevention of Seasonal Influenza
CAMBRIDGE, MA / ACCESS Newswire / August 5, 2026 / -- Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mFLUSIVA® (mRNA-1010), a new vaccine aga
FDA Approves Gwyn Lo (norelgestromin and ethinyl estradiol) Once-Weekly Contraceptive Patch
PITTSBURGH, July 29, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved Gwyn Lo™ (norelgestrom
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