The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety?
The FDA's decision not to approve Spero Therapeutics' oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic re
Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA's Vaccines and Related Biological Produc
Jennifer Mathieu, vice president of policy and government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchang
Shares in Sarepta came under pressure after the biotech said it had temporarily halted a clinical trial of its new-generation Duchenne muscular dystrophy candidate, after a patient had a se
The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products was limited and regulatory inspections became difficult to carry out.