News NICE says no to Genmab cervical cancer therapy Genmab's recently approved therapy for relapsed cervical cancer has been turned down for NHS use in initial NICE guidance.
News FDA approves leucovorin – but not for autism The FDA stops short of approving leucovorin for autism, but will its clearance for ultra-rare condition CFD-FOLR1 lead to more off-label prescribing?
News FDA cuts testing requirements for biosimilars once again The FDA has issued additional guidance that aims to make it easier for drugmakers to bring biosimilars of patent-expired biologic drugs to market.
News Incyte breaks new ground in anal cancer with EU approval Incyte claims EU approval for Zynyz as the first systemic therapy for anal cancer, as J&J gets the nod for wider use of Akeega in prostate cancer.
News CBER chief Vinay Prasad to leave FDA once again For the second time in less than a year, Vinay Prasad has departed from the FDA, after a string of controversial regulatory decisions.
News China's clears Pfizer GLP-1 ecnoglutide for weight loss Pfizer has claimed its first regulatory approval for a GLP-1 agonist in obesity, getting a green light in China for Sciwind-sourced ecnoglutide.
News Recordati gets €10.9bn takeover bid from private equity firm Recordati has received a takeover offer from private equity group CVC that, if completed, would delist it from the Italian stock exchange.
Sales & Marketing Sponsored Using AI-driven synthetic personas to take your insights fur... As AI continues to reshape the healthcare landscape, pharma teams are beginning to leverage synthetic personas.
