FDA posts an updated draft guidance outlining new and revised recommendations for companies developing biosimilar products.
FDA sends Incyte a complete response letter for its supplemental BLA for Zynyz (retifanlimab-dlwr) injection that cited inspection findings (not spec...
Consumer advocacy group Public Citizen urges Pfizer to commit to maintaining access to its medicines in Europe after comments by CEO Albert Bourla sug...
Roche reports that its investigational breast cancer drug giredestrant failed to significantly extend progression-free survival in a Phase 3 study whe...
FDA says it recently held a meeting with several states to discuss implementation of a program that would allow the importation of certain lower-cost ...
Xenon Pharmaceuticals says its experimental epilepsy drug azetukalner met the primary endpoint in a late-stage clinical trial in patients with focal o...
Ipsen voluntarily withdraws Tazverik (tazemetostat) from the market based on emerging data from the ongoing Phase 1b/3 SYMPHONY-1 trial due to safety ...
FDA investigators cite manufacturing and documentation issues at an Indian sterile drug facility operated by Maiva Pharma Private Ltd. following an in...
