BMS Reports Positive Phase 3 SCOUT-HCM Results for Camzyos in Teens with oHCM Bristol Myers Squibb today announced positive topline results from SCOUT-HCM, a Phase 3 trial evaluating Camzyos (mavacamten) in the first study of a cardiac myosin inhibitor (CMI) in adolescents…
Gordian Bio Enters Research Partnership with Pfizer to Drive Obesity Target Discovery Gordian Bio, a biotechnology company pioneering large-scale in vivo functional genomics to unlock validated drug targets for chronic diseases, today announced a non-exclusive research collaboration with Pfizer to…
The appointment strengthens leadership of the company’s U.S. BioPharmaceuticals operations and strategic growth AstraZeneca has named Rick R. Suarez Senior Vice President, US President and Head of the US BioPharmaceuticals Business Unit.Suarez will lead the execution of the Company’s previously…
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…
