Ipsen voluntarily withdraws Tazverik (tazemetostat) from the market based on emerging data from the ongoing Phase 1b/3 SYMPHONY-1 trial due to safety concerns.
FDA posts an updated draft guidance outlining new and revised recommendations for companies developing biosimilar products.
Ipsen voluntarily withdraws Tazverik (tazemetostat) from the market based on emerging data from the ongoing Phase 1b/3 SYMPHONY-1 trial due to safety concerns.
FDA posts an updated draft guidance outlining new and revised recommendations for companies developing biosimilar products.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 specific to Zynyz) at Catalent Indiana, part of Novo Nordisk, the third-party fill-finish facility referenced in the sBLA.
Consumer advocacy group Public Citizen urges Pfizer to commit to maintaining access to its medicines in Europe after comments by CEO Albert Bourla suggesting the company could stop supplying drugs to France if governments refuse to pay higher prices.
