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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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FDA Approves Oriahnn (elagolix/estradiol/norethindrone acetate and elagolix) for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-Menopausal Women

NORTH CHICAGO, Ill., May 29, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), in cooperation with Neurocrine Biosciences, Inc. (Nasdaq: NBIX), announced that the U.S. Food and Drug Administration (FDA) appro

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