Injury or Poisoning
FDA Delays Blenrep Decision, Challenging GSK’s Multiple Myeloma Comeback Plans
FDA delay; Blenrep; GSK; multiple myeloma; regulatory hurdles; ocular toxicity; PDUFA; oncology; relapsed/refractory
FDA Advisory Panel Rejects GSK’s Blenrep in New Combinations Over Safety, Efficacy Concerns
Blenrep; GSK; FDA Advisory Panel; multiple myeloma; ocular toxicity; safety concerns; DREAMM trials; drug approval; relapsed or refractory multiple myeloma
Pfizer’s Strategic Shift Post-Danuglipron: Exploring New Frontiers in Obesity Treatment
Pfizer, danuglipron, obesity treatment, GLP-1 receptor agonist, liver injury, weight-loss drugs, GLP-1/GIP therapies, pharmaceutical competition, metabolic diseases, Viking Therapeutics, obesity pipeline
FDA Updates Label for Agios’ PYRUKYND with New Liver Injury Warning
Agios Pharmaceuticals, PYRUKYND, mitapivat, liver injury warning, FDA label update, thalassemia treatment
FDA Approves Humacyte’s Symvess: A Revolutionary Off-the-Shelf Artery Implant for Vascular Trauma Repair
FDA Approval, Humacyte, Symvess, Vascular Trauma, Off-the-Shelf Artery Implant, Bioengineered Human Tissue, Extremity Vascular Trauma Treatment
FDA Warns of Serious Liver Injury Risk with Ocaliva (Obeticholic Acid) in Patients with Primary Biliary Cholangitis
Ocaliva, obeticholic acid, liver injury, FDA warning, primary biliary cholangitis, liver disease, medication safety
Ocaliva (Obeticholic Acid) Linked to Increased Risk of Liver Failure in PBC Patients Without Cirrhosis
Ocaliva, obeticholic acid, primary biliary cholangitis (PBC), liver failure, liver injury, cirrhosis, FDA warning.
Agios’ Thalassemia Drug Mitapivat Faces Liver Injury Concerns Despite Second Phase III Success
Agios Pharmaceuticals, Mitapivat, Thalassemia, Liver Injury, Phase III Trials, ENERGIZE-T Study, Regulatory Approval
Pfizer Announces Layoffs in Ireland Amid Global Cost-Cutting Efforts
Pfizer layoffs, Ireland, cost-cutting, pharmaceutical industry, job cuts
Pharmaceutical Giants J&J and Bayer Announce Layoffs of Nearly 300 Employees in New Jersey
Johnson & Johnson, Bayer, layoffs, New Jersey, pharmaceutical industry, job cuts