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 J&J's Tecvayli claims third national priority FDA approval J&J claims the FDA's third national priority voucher approval, advancing a Tecvayli-based regimen for multiple myeloma into the second-line setting.
News Hansa closes on FDA verdict for transplant drug imlifidase The FDA has started reviewing Hansa's imlifidase for highly sensitised adults needing a kidney transplant, but not in the requested rapid timeframe.
News Ascendis scores FDA approval for weekly dwarfism drug Children with achondroplasia will soon have the option of a once-weekly - rather than daily - injection, courtesy of Ascendis' newly approved Yuviwel.
News CMS extends deadline for MFN pricing pilot scheme CMS has extended the deadline for its Medicaid drug pricing pilot, GENEROUS, to "provide interested drug manufacturers more opportunity to join."
News Lilly partners with Hims & Hers on obesity drug sales Eli Lilly has signed an agreement with Hims & Hers that will see its weight-loss therapies sold directly on the telehealth company's platform.
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