NDA News-CliniExpert

FDA Approves RediTrex (methotrexate) for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, and Psoriasis

NASHVILLE, Tenn., Dec. 2, 2019 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that it has received approval from the U.S. Food and

FDA Approves Oxbryta (voxelotor) for the Treatment of Sickle Cell Disease

SOUTH SAN FRANCISCO, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) -- Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) today announced that the U.S. Food and Drug Administration (FDA) has granted accelera

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

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

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

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

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

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