NDA News-CliniExpert

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

FDA Approves Jelmyto (mitomycin gel) for Treatment of Low-Grade Upper Tract Urothelial Cancer

April 15, 2020 -- Today, the U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC). Urothelial cancer is a cance

FDA Approves Koselugo (selumetinib) for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas

13 April 2020 -- AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approv

FDA Approves Sevenfact [coagulation factor VIIa (recombinant)-jncw] for Treatment and Control of Bleeding Episodes Occurring in Adult and Adolescent Hemophilia A and B Patients with Inhibitors

LOUISVILLE, Ky., April 6, 2020 /PRNewswire/ -- HEMA Biologics, LLC, ("HEMA Biologics") today announced that the U.S. Food and Drug Administration (FDA) approved Sevenfact® [coagulation facto

FDA Approves Zeposia (ozanimod) for Relapsing Forms of Multiple Sclerosis

PRINCETON, N.J.--(BUSINESS WIRE) -- Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) 0.92 mg for the treatment of a

FDA Approves Isturisa (osilodrostat) for the Treatment of Cushing’s Disease

March 06, 2020 -- The U.S. Food and Drug Administration today approved Isturisa (osilodrostat) oral tablets for adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have