NDA News-CliniExpert

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

FDA Approves Qelbree (viloxazine) for the Treatment of ADHD

ROCKVILLE, Md., April 02, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of ce

FDA Approves Abecma (idecabtagene vicleucel) as the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma

PRINCETON, N.J., & CAMBRIDGE, Mass.--(BUSINESS WIRE) March 26, 2021 -- Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administra

FDA Approves Zegalogue (dasiglucagon) Injection for the Treatment of Severe Hypoglycemia in People with Diabetes

Copenhagen, DK and Boston, MA, U.S. March 22, 2021 -- Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company aspiring to deliver innovation with novel peptide therapeutics, anno

FDA Approves Ponvory (ponesimod) for the Treatment of Adults with Relapsing Multiple Sclerosis

TITUSVILLE, N.J. – (March 19, 2021) -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) approved Ponvory™ (ponesimod), a o

FDA Approves Kimyrsa (oritavancin) for the Treatment of Adult Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

MORRISTOWN, N.J., March 15, 2021 (GLOBE NEWSWIRE) — Melinta Therapeutics, LLC (Melinta), a commercial-stage company focused on the development and commercialization of novel antibiotics, today announc