FDA Approves Itovebi (inavolisib) for the Combination Treatment of Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

South San Francisco, CA -- October 10, 2024 -- Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) approved Itovebi (inavolisib), in combination wi

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FDA Approves Flyrcado (flurpiridaz F 18) Radioactive Diagnostic for Enhanced Diagnosis of Coronary Artery Disease

ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE) September 27, 2024 -- GE HealthCare (Nasdaq: GEHC) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of Flyrcado (flurpirid

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FDA Approves Otulfi (ustekinumab-aauz), a Biosimilar to Stelara

September 30, 2024 -- Fresenius Kabi, an operating company of Fresenius, specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic c

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FDA Approves Cobenfy (xanomeline and trospium chloride), a First-In-Class Muscarinic Agonist for the Treatment of Schizophrenia in Adults

PRINCETON, N.J. -- (BUSINESS WIRE) -- 26 September 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospi

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FDA Approves Aqneursa (levacetylleucine) for the Treatment of Niemann-Pick Disease Type C

AUSTIN, TX, September 25, 2024 -- IntraBio Inc., a leader in the discovery and development of innovative drugs for rare neurodegenerative diseases, today announced that the U.S. Food and Drug Administ

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FDA Approves Miplyffa (arimoclomol) for the Treatment of Niemann-Pick Disease Type C

CELEBRATION, Fla., Sept. 20, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage rare disease therapeutics company, today announced that the

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FDA Approves Ebglyss (lebrikizumab-lbkz) for the Treatment of Atopic Dermatitis

INDIANAPOLIS, Sept. 13, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today the U.S. Food and Drug Administration (FDA) approved Ebglyss (lebrikizumab-lbkz), a targeted IL-13 inhibi

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FDA Approves Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) Twice-A-Year Subcutaneous Injection for People With Relapsing and Progressive Multiple Sclerosis

South San Francisco, CA -- September 13, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (U.S. FDA) has

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FDA Approves Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

South San Francisco, CA -- September 12, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tece

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FDA Approves Pavblu (aflibercept-ayyh), a Biosimilar to Eylea

August 23, 2024 -- The U.S. Food and Drug Administration (FDA) has announced the approval of Pavblu (aflibercept-ayyh) 2 mg injection (single-dose prefilled syringe and single-dose vial) for intravitr

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FDA Approves Crexont (carbidopa and levodopa) Extended-Release Capsules for the Treatment of Parkinson’s Disease

BRIDGEWATER, N.J.--(BUSINESS WIRE) August 7, 2024 -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approv

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FDA Approves Rybrevant (amivantamab-vmjw) Plus Lazcluze (lazertinib) for Patients with EGFR-Mutated Advanced Lung cancer

RARITAN, N.J., Aug. 20, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved Rybrevant® (amivantamab-vmjw) plus Lazcluze™ (l

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