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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

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

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

FDA Approves Zilxi (minocycline) Topical Foam for the Treatment of Rosacea

BRIDGEWATER, N.J., May 29, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing prop

FDA Approves Tauvid (flortaucipir F 18 injection) for Use in Patients Being Evaluated for Alzheimer's Disease

INDIANAPOLIS, May 28, 2020 /PRNewswire/ -- Tauvid, a radioactive diagnostic agent, has been approved by the FDA for positron emission tomography (PET) imaging of the brain to estimate the density and

FDA Approves Artesunate for Injection for the Treatment of Severe Malaria

FREDERICK, Md., May 27, 2020 /PRNewswire/ -- Amivas (US), LLC, specialists in treatments for rare and neglected tropical diseases, including severe malaria, announced today that Artesunate for Injecti

FDA Approves Phexxi (lactic acid, citric acid and potassium bitartrate) Non-Hormonal Prescription Gel for the Prevention of Pregnancy

SAN DIEGO, May 22, 2020 /PRNewswire/ -- Evofem Biosciences, Inc. (NASDAQ: EVFM) today announced that the U.S. Food and Drug Administration (FDA) has approved Phexxi™ (lactic acid, citric acid and pota