Biogen and Sage Therapeutics' zuranolone has become the first oral drug to be approved by the FDA for post-partum depression (PPD), but the US regulator turned down a requ
GSK has claimed US approval for Jemperli alongside chemotherapy for previously untreated, primary advanced or recurrent endometrial cancer, becoming the first immunotherap
AstraZeneca's Soliris has become the first approved treatment in the EU for children and adolescents with generalised myasthenia gravis, a disorder that causes weakness in
Boehringer Ingelheim and Eli Lilly's SGLT2 inhibitor Jardiance has been approved for chronic kidney disease in the EU - the first major market to clear the new use for the
Bavarian Nordic is preparing to file for regulatory approval of a vaccine against chikungunya virus after its CHIKV VLP candidate showed protective efficacy in a second ph
To improve trial recruitment, engagement, and retention, and to increase the likelihood that trials reflect what matters most to patients, regulatory authorities increasingly point to metho