Saturday, March 14, 2020

FDA Approves Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for Cystic Fibrosis Patients Ages 12 and Older Who Have at Least One F508del Mutation

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In continuation of my update on    tezacaftor   and ivacaftor Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the...
Friday, March 13, 2020

FDA Approves Amzeeq (minocycline) Topical Foam for the Treatment of Moderate to Severe Acne

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Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) (“Foamix” or the “Company”), a specialty pharmaceutical company, announced  the U.S. Fo...
Thursday, March 12, 2020

FDA Approves Secuado (asenapine) Transdermal System for the Treatment of Adults with Schizophrenia

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In continuation of my update on  Asenapine Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutica...
Wednesday, March 11, 2020

FDA Approves Reyvow (lasmiditan), the First Serotonin (5-HT) 1F Receptor Agonist for the Acute Treatment for Migraine

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Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved  Reyvow  (lasmiditan) an...
Tuesday, March 10, 2020

FDA Approves Quzyttir (cetirizine) Injection for the Treatment of Acute Urticaria

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The U.S. Food and Drug Administration (FDA) has approved Quzyttir (cetirizine hydrochloride) injection for the treatment of acute urticari...
Monday, March 9, 2020

FDA Approves Scenesse (afamelanotide) for Prevention of Phototoxicity in Erythropoietic Protoporphyria

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The U.S. Food and Drug Administration  has  granted approval to Scenesse (afamelanotide) to increase pain-free light exposure in adult...
Saturday, March 7, 2020

FDA Approves Bonsity (teriparatide injection) to Treat Osteoporosis

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In continuation of my update on  teriparatide Pfenex Inc. (NYSE American: PFNX) announced today that the U.S. Food and Drug Admini...
Friday, March 6, 2020

FDA Approves Aklief (trifarotene) Cream, a New Topical Retinoid for the Treatment of Acne

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Galderma, a global leader focused on meeting the world's increasing skin health needs, announced today that the U.S. Food and Dr...
Thursday, March 5, 2020

FDA Approves Xcopri (cenobamate) for the Treatment of Partial-Onset Seizures in Adults

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  In continuation of my update on  cenobamate SK Biopharmaceuticals, Co., Ltd., an innovative global pharmaceutical company focuse...
Wednesday, March 4, 2020

FDA Approves Givlaari (givosiran) for Acute Hepatic Porphyria

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Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Adminis...
Tuesday, March 3, 2020

FDA Approves Fetroja (cefiderocol) for the Treatment of Complicated Urinary Tract Infections

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The U.S. Food and Drug Administration approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age ...
Monday, March 2, 2020

FDA Approves Brukinsa (zanubrutinib) for the Treatment of Mantle Cell Lymphoma

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BeiGene, Ltd.,  a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted...
Saturday, February 29, 2020

FDA Approves Reblozyl (luspatercept-aamt) for the Treatment of Anemia in Adults With Beta Thalassemia Who Require Regular Red Blood Cell Transfusions

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In continuation of my update on  Luspatercept   Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today anno...