March 2025
Drugmakers fear Trump tariffs will drive up manufacturing costs, hurt medicine access: BIO survey
Manufacture, EU, Surveys, Financial cost, Fear (Mental Process), Bio
FDAs policy, communications staff likely to be among agencys 3,500 staff cuts
Policy, Communication, Staff, United States Food and Drug Administration, CHARGE Syndrome
Alcon Secures Control of Aurion Biotech in Strategic Takeover
Alcon, Aurion Biotech, majority stake, CEO replacement, cell therapy, corneal endothelial disease, AURN001, IPO dispute
Soleno breaks through with FDA nod for Prader-Willi syndrome treatment Vykat XR
FDA approval, Vykat XR, Prader-Willi syndrome, hyperphagia, Soleno Therapeutics, diazoxide choline
Wave Life Sciences’ WVE-N531 Shows Promise in Duchenne Muscular Dystrophy Treatment
Duchenne muscular dystrophy (DMD), WVE-N531, exon 53 skipping, Phase II trial, dystrophin expression, muscle health improvement, FDA approval
FDA clears Exelixis’ TKI for neuroendocrine tumours
CABOMETYX, cabozantinib, neuroendocrine tumors, FDA approval, Exelixis, tyrosine kinase inhibitor
Trump Tariffs Could Delay Regulatory Filings for Half of Biotech Companies
Tariffs, Biotechnology, Regulatory filings, Manufacturing costs, Supply chain disruption
Kaken Secures Japanese Rights for Alumis’ Novel TYK2 Inhibitor ESK-001
Alumis, Kaken Pharmaceutical, ESK-001, TYK2 inhibitor, dermatology, licensing agreement, Japan
J&J combo signals new era in EGFR lung cancer with survival win against AstraZeneca’s Tagrisso
Continuance of life, Combined, Epidermal Growth Factor Receptor, Malignant neoplasm of lung, Overall Survival, Tagrisso
Senate confirms Johns Hopkins surgeon Marty Makary to lead FDA amid turbulence at the agency
Makary, Senate, United States Food and Drug Administration, Surgeon, Johns, Agencies, Dr., Marty