News Lilly gets approval for earlier use of Jaypirca in CLL Eli Lilly's fast-growing Jaypirca has won a new FDA approval as an earlier treatment for relapsed/refractory chronic lymphocytic leukaemia.
News Tracy Beth Hoeg will be fifth CDER head this year Tracy Beth Høeg, who has very little regulatory experience, is making the switch from CBER to replace FDA veteran Richard Pazdur.
News Appeals court turns Enhertu patent dispute on its head A US appeals court has reversed a 2023 decision that ordered Daiichi Sankyo to pay royalties on sales of cancer drug Enhertu to Seagen (now Pfizer).
News AZ uses a priority review voucher for baxdrostat filing Seeking a lead over rival Mineralys, AstraZeneca is using a priority review voucher for its US filing for uncontrolled hypertension drug baxdrostat.
News Pazdur to leave FDA, shortly after taking CDER job Long-serving FDA figure Richard Pazdur has filed papers to retire, shortly after being appointed to lead CDER, according to reports.
News J&J gets EU approval for Imaavy in gMG J&J's Imaavy has become the first FcRn blocker to be approved in the EU for both adolescent and adult patients with generalised myasthenia gravis.
Digital AI, start-ups, and the future of human health: AION Labs’ Ma... In a new episode of the pharmaphorum podcast, Nicole Raleigh invites Mati Gill, CEO of AION Labs, back as guest.
Digital Sponsored Discover a new era of healthcare panel engagement: Grounded ... A new webinar from Konovo will address some of the critical topics impacting today’s healthcare market research industry.