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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

FDA Approves Kynmobi (apomorphine hydrochloride) Sublingual Film for the Treatment of Parkinson’s Disease OFF Episodes

MARLBOROUGH, Mass.--(BUSINESS WIRE) May 21, 2020 -- Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has approved Kynmobi (apomorphine HCI) sub

FDA Approves Qinlock (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor

WALTHAM, Mass.--(BUSINESS WIRE)--May 15, 2020 -- Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the U.S. Food and Drug Administration (FDA) has approved Qinlock™ (ripretinib) for the tr

FDA Approves Retevmo (selpercatinib) for Patients with Advanced RET-Driven Lung and Thyroid Cancers

INDIANAPOLIS, May 8, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved Retevmo™ (selpercatinib, 40 mg & 80 mg capsule

Tonix Pharmaceuticals Announces Research Collaboration with Southern Research to Develop a Potential Vaccine to Protect Against New Coronavirus Disease 2019 (COVID-19) Based on Horsepox Virus (TNX-1800)

NEW YORK, Feb. 26, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today a strategic collabora

Gilead Sciences Initiates Two Phase 3 Studies of Investigational Antiviral Remdesivir for the Treatment of COVID-19

FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 26, 2020 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the initiation of two Phase 3 clinical studies to evaluate the safety and efficacy of remdes

Y-mAbs Announces Positive Pre-BLA Meeting with FDA for Omburtamab

NEW YORK, Feb. 26, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commerci

FDA Approves Tabrecta (capmatinib) for Metastatic Non-Small Cell Lung Cancer with METex14

EAST HANOVER, N.J., May 6, 2020 /PRNewswire/ -- Novartis announced today that the US Food and Drug Administration (FDA) approved Tabrecta™ (capmatinib, formerly INC280), an oral MET inhibitor for adul

FDA Approves Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Multiple Myeloma

HORSHAM, Pa., May 1, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro (daratumuma

FDA Approves Fensolvi (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty

BUFFALO GROVE, Ill., May 4, 2020 /PRNewswire/ -- Tolmar Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application for Fensolvi (leupr

Moderna Ships mRNA Vaccine Against Novel Coronavirus (mRNA-1273) for Phase 1 Study

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 24, 2020 -- Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new gener