NDA News-CliniExpert

FDA Approves Brexafemme (ibrexafungerp) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections

JERSEY CITY, N.J., June 02, 2021 (GLOBE NEWSWIRE) -- Scynexis, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistan

FDA Approves Lumakras (sotorasib) for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

THOUSAND OAKS, Calif., May 28, 2021 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Lumakras (sotorasib) for the treatment of adult p

FDA Approves Truseltiq (infigratinib) for the Treatment of Cholangiocarcinoma

PALO ALTO, Calif. and LUGANO, Switzerland, May 28, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group today announced that

FDA Approves Lybalvi (olanzapine and samidorphan) for the Treatment of Schizophrenia and Bipolar I Disorder

DUBLIN, June 1, 2021 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved Lybalvi (olanzapine and samidorphan) for the treatment of

FDA Approves Myfembree as the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids

BASEL, Switzerland and NEW YORK, May 26, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approve

FDA Approves Rybrevant (amivantamab-vmjw) as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

May 21, 2021 (HORSHAM, P.A.) -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has granted the accelerated approval of Rybrev

FDA Approves Empaveli (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)

WALTHAM, Mass., May 14, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the U.S. Foo

FDA Approves Zynrelef (bupivacaine and meloxicam) for the Management of Postoperative Pain

SAN DIEGO, May 13, 2021 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatme

FDA Approves Kloxxado (naloxone hydrochloride) Nasal Spray for Emergency Treatment of Opioid Overdose

LONDON, April 30, 2021 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the approval of Kloxxado (naloxone hydrochloride) nasal spray 8mg, by the

FDA Approves Zynlonta (loncastuximab tesirine-lpyl) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

LAUSANNE, Switzerland--(BUSINESS WIRE) APRIL 23, 2021 -- ADC Therapeutics SA (NYSE: ADCT) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynlonta (loncastuximab tesirine

FDA Approves Jemperli (dostarlimab-gxly) for Women with Recurrent or Advanced dMMR Endometrial Cancer

London UK 22 April 2021 -- GlaxoSmithKline today announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibo

FDA Approves Nextstellis (drospirenone and estetrol) Oral Contraceptive for Birth Control

15 April 2021 - Adelaide, Australia and Liege, Belgium -- Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are very pleased to announce that the US Food