NDA News-CliniExpert

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

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

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

FDA Approves Ongentys (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes

SAN DIEGO – April 27, 2020 – Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Ongentys (opicapone) 25 mg and 50