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

Latest News NDA News 1784
• Read All

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

Latest News NDA News 2553
• Read All

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

Latest News NDA News 2186
• Read All

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

Latest News NDA News 1809
• Read All

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

Latest News NDA News 1781
• Read All

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

Latest News NDA News 2218
• Read All

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

Latest News NDA News 2095
• Read All

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

Latest News NDA News 1860
• Read All

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

Latest News NDA News 2172
• Read All

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

Latest News NDA News 5227
• Read All

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

Latest News NDA News 4857
• Read All

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

Latest News NDA News 2060
• Read All
News
- CanalLotus Biotech -
Int'l Clinical Service Expert

We are the leader
Because of our professionism