Takeda and Protagonist File NDA for Rusfertide in Polycythemia Vera Takeda Pharmaceutical Company Limited and Protagonist Therapeutics, Inc. have announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for rusfertide, an investigational…
Bayer Regulatory milestones build on FDA’s recent accelerated approval for previously treated HER2-mutant lung cancer patients Bayer announced that regulatory authorities in both the United States and China have granted Breakthrough Therapy Designation to sevabertinib as a potential first-line treatment…
Finerenone Receives Approval in Japan for Chronic Heart Failure Treatment Bayer today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved finerenone (Kerendia™), a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA), for the treatment of adult patients with…
FDA Approves Subcutaneous Form of Roche’s Lunsumio VELO™ for Relapsed or Refractory Follicular Lymphoma Roche announced today that the US Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO™ (mosunetuzumab), as a subcutaneous (SC) formulation, for the treatment…
Cytokinetics Announces FDA Approval of MYQORZO™ for Symptomatic Obstructive HCM in Adults Cytokinetics, Incorporated today announced that the U.S. Food and Drug Administration (FDA) has approved MYQORZO™, 5 mg, 10 mg, 15 mg, 20 mg tablets for the treatment of adults…
BioNTech Completes Acquisition of CureVac N.V., Including Follow-on Offering Period, to Bolster Its Leading Position in the mRNA Space BioNTech SE today announced the closing of its acquisition of CureVac N.V and that the subsequent offering period of the exchange offer…
Incyte Announces EU Approval of Minjuvi® for R/R Follicular Lymphoma Incyte today announced that the European Commission (EC) has approved Minjuvi® (tafasitamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a)…
U.S. FDA Approves RYBREVANT® FASPRO™ (amivantamab and hyaluronidase-lpuj), Offering the Shortest and Simplest Administration Time for a First-Line Combination Regimen with LAZCLUZE® (lazertinib) Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT FASPRO™ (amivantamab and…
Grifols Secures European Medicines Agency Approval for Grifols Egypt’s Full Value Chain Grifols, S.A., a global leader in plasma-derived medicines and innovative healthcare solutions, has received certification from the European Medicines Agency (EMA) for the entire value chain of Grifols…
Exdensur (depemokimab) Approved in the UK for Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps GSK plc today announced the marketing authorisation of Exdensur (depemokimab) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In the UK, Exdensur is now…
Aflibercept 8 mg Recommended for EU Approval for Third Retinal Indication The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended aflibercept 8 mg (114.3 mg/ml solution for injection) for marketing authorization in…
U.S. FDA Approves AKEEGA®—First Precision Therapy for BRCA2-Mutated Metastatic Castration-Sensitive Prostate Cancer, Cutting Disease Progression by 54% Compared to Standard of Care* Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approvedthe supplemental New Drug Application (sNDA)…
