NDA News-CliniExpert

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

FDA Approves MenQuadfi (Meningococcal (Groups A, C, Y, W) Conjugate Vaccine) for Meningococcal (MenACWY) Vaccination

PARIS – April 24, 2020 – The U.S. Food and Drug Administration (FDA) has approved a Biologics License Application for MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine for the prevention o

FDA Approves Trodelvy (sacituzumab govitecan-hziy) for Previously-Treated Metastatic Triple Negative Breast Cancer

Morris Plains, N.J., April 22, 2020 — Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today anno

FDA Approves Tukysa (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer

BOTHELL, Wash.--(BUSINESS WIRE) April 17, 2020 -- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced the U.S. Food and Drug Administration (FDA) granted approval to Tukysa™ (tucatinib) tablets in co

FDA Approves Pemazyre (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma

WILMINGTON, Del.--(BUSINESS WIRE)--Apr. 17, 2020 -- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Pemazyre (pemigatinib), a kinase inhibitor indica