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

November 14, 2019 -- The U.S. Food and Drug Administration today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract

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

CAMBRIDGE, Mass. and BEIJING, China, Nov. 14, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing

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

SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE) -- Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced the U.S. Food and Drug Administration (FDA) has appr

FDA Approves Ziextenzo (pegfilgrastim-bmez), a Biosimilar to Neulasta

Holzkirchen, Nov. 5, 2019 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar Ziextenzo (pegfilgras

FDA Approves Talicia (omeprazole magnesium, amoxicillin and rifabutin) for the Treatment of H. pylori Infection in Adults

TEL-AVIV, Israel and RALEIGH, N.C., Nov. 04, 2019 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical

PellePharm Completes Enrollment Of Pivotal Phase 3 Clinical Trial Of Patidegib Topical Gel In Patients With Gorlin Syndrome

SAN FRANCISCO – December 2, 2019 – PellePharm, Inc., a BridgeBio Pharma, Inc. (Nasdaq: BBIO) company, today announced the completion of enrollment for its pivotal Phase 3 clinical trial of Patidegib T

Positive Phase III Results for Genentech’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in the New England Journal of Medicine

South San Francisco, CA -- December 1, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that data from SAkuraSky, a pivotal Phase III study of the investiga

The Medicines Company Announces that the ORION-9 Study of Inclisiran in HeFH Patients Showed Durable and Potent LDL-C Lowering with Twice-Yearly Dosing

November 18, 2019 -- The Medicines Company (NASDAQ: MDCO) today announced detailed results from ORION-9, the last of three pivotal 18-month low-density lipoprotein cholesterol (LDL-C) lowering Phase 3

New England Journal of Medicine Publishes Results of Ebola Clinical Trial Confirming Superiority of Regeneron's REGN-EB3 to ZMapp in Preventing Ebola Deaths

TARRYTOWN, N.Y., Nov. 27, 2019 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced today that the New England Journal of Medicine(NEJM) published results from the randomized contr

Chi-Med Announces Surufatinib Granted FDA Orphan Drug Designation for Pancreatic Neuroendocrine Tumors

LONDON, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug desi

FDA Grants Priority Review to Genentech’s Risdiplam for Spinal Muscular Atrophy

South San Francisco, CA -- November 24, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the N

Pivotal Data from Phase 3 Study of Sutimlimab in Cold Agglutinin Disease to be Presented at ASH 2019 Late-Breaking Session

CAMBRIDGE, Mass., Nov. 21, 2019 /PRNewswire/ -- Sanofi, Full data from the pivotal Phase 3 CARDINAL trial evaluating the safety and efficacy of sutimlimab in people with primary cold agglutinin diseas