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FDA Approves Byfavo (remimazolam injection) for the Induction and Maintenance of Procedural Sedation

Dublin, Ireland – 2 July 2020 -- Cosmo Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has approved Byfavo (remimazolam injection) for the induction and maintenance of p

FDA Approves Rukobia (fostemsavir) for HIV in Adults with Few Treatment Options Available

July 2, 2020 -- ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administratio

FDA Approves Dojolvi (triheptanoin) for the Treatment of Long-Chain Fatty Acid Oxidation Disorders

NOVATO, Calif., June 30, 2020 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for rare

FDA Approves Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) for HER2-Positive Breast Cancer Print this page

South San Francisco, CA -- June 29, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Phesgo, a

FDA Approves Fintepla (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome

EMERYVILLE, Calif., June 25, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Admin

FDA Approves Mycapssa (octreotide) Oral Somatostatin Analog for Acromegaly

NEEDHAM, Mass., June 26, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ: CHMA), a commercial stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) approved

FDA Approves Gimoti (metoclopramide) Nasal Spray for Diabetic Gastroparesis

SOLANA BEACH, Calif., June 19, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced

FDA Approves Zepzelca (lurbinectedin) for the Treatment of Metastatic Small Cell Lung Cancer

Madrid and Dublin, June 15th, 2020. -- PharmaMar (MSE:PHM) has today announced, along with Jazz Pharmaceuticals plc (Nasdaq: JAZZ), that the U.S. Food and Drug Administration (FDA) has approved Zepzel

FDA Approves Lyumjev (insulin lispro-aabc injection) for Type 1 and Type 2 Diabetes

INDIANAPOLIS, June 15, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and Company's

FDA Approves Semglee (insulin glargine injection) for Type 1 and Type 2 Diabetes

HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 11, 2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food an

FDA Approves Uplizna (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD)

GAITHERSBURG, Md., June 11, 2020 (GLOBE NEWSWIRE) -- Viela Bio (Nasdaq:VIE) today announced that the U.S. Food and Drug Administration (FDA) has approved Uplizna (inebilizumab-cdon) for the treatment

FDA Approves Nyvepria (pegfilgrastim-apgf), a Biosimilar to Neulasta

NEW YORK--(BUSINESS WIRE)-- June 11, 2020 -- Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Nyvepria (pegfilgrastim-apgf), a biosimila