Some patients with COVID-19 will be able to get easier access to Pfizer's oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug.
The FDA has started an accelerated review of Eisai and Biogen's a new amyloid-targeting antibody lecanemab for Alzheimer's disease, with a 6 January deadline that keep them ahead of closest
The FDA has granted a priority review to Roche's T-cell engager Lunsumio as a treatment for follicular lymphoma (FL), setting up a decision on the drug by 29 December.
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
Gilead Sciences has refiled for FDA approval of its HIV capsid inhibitor lenacapavir – which only needs to be dosed every six months – after the drug was rejected by the regulator in Februa