PHARMASHOTS NEWSWIRE

UCB receives U.S. FDA approval for BIMZELX[®] (bimekizumab-bkzx) as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa

21 Nov 2024

Regulatory

  global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved BIMZELX® (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS).1 Bimekizumab-bkzx is the first and only approved medicin

Jazz Pharmaceuticals Announces U.S. FDA Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary

21 Nov 2024

Regulatory

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastat

Pharmanovia Signs Novel Biologic In-Licensing Agreement With Lindis Biotech to Commercialise Catumaxomab for Treatment of Rare Condition, Malignant Ascites

20 Nov 2024

Pharma

Pharmanovia, a global pharmaceutical company that commercialises novel medicines and revitalises, extends and expands the lifecycle of established medicines, has today announced the expansion of its oncology portfolio with a new licensing agreement for catumaxomab, for the treatment of malignant asc

Sangamo Therapeutics Announces U.S. FDA Clearance of IND Application for ST-503 for the Treatment of Idiopathic Small Fiber Neuropathy, a Type of Chronic Neuropathic Pain

20 Nov 2024

Regulatory

Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for its ST-503 program, an investigational epigenetic regulator for the treatment of intra

European Commission Approves Pfizer’s HYMPAVZI™ (marstacimab) for the Treatment of Adults and Adolescents with Severe Hemophilia A or B Without Inhibitors

20 Nov 2024

Regulatory

Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for HYMPAVZI™ (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe hemophilia A (congenital fac

ESSENCE Phase 3 trial results demonstrating statistically significant and superior improvements with semaglutide 2.4 mg in people with MASH presented at AASLD 2024 - The Liver Meeting®

20 Nov 2024

Clinical Trials

Novo Nordisk today announced results from part 1 of the ongoing Phase 3 ESSENCE trial. Part 1 evaluated the effect of once-weekly subcutaneous semaglutide 2.4 mg on liver tissue (histology) compared with placebo in people with metabolic dysfunction-associated steatohepatitis (MASH) and moderate



Load More...