FDA Approves Exservan (riluzole) Oral Film for the Treatment of Amyotrophic Lateral Sclerosis

WARREN, N.J., Nov. 25, 2019 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products to sol

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

PANGYO, South Korea and PARAMUS, N.J., Nov. 21, 2019 /PRNewswire/ -- SK Biopharmaceuticals, Co., Ltd., an innovative global pharmaceutical company focused on developing and bringing treatments to mark

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FDA Approves Givlaari (givosiran) for Acute Hepatic Porphyria

CAMBRIDGE, Mass.--(BUSINESS WIRE) November 20, 2019 --Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (F

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FDA Approves Abrilada (adalimumab-afzb), a Biosimilar to Humira

November 18, 2019 - Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Abrilada™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab

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FDA Approves Adakveo (crizanlizumab-tmca) to Reduce Frequency of Pain Crises in Individuals Living with Sickle Cell Disease

Basel, November 15, 2019 – Novartis announced today that the US Food and Drug Administration (FDA) approved Adakveo (crizanlizumab), previously known as SEG101, to reduce the frequency of vaso-occlusi

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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

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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

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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

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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

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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

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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

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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

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