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
The final obstacle to the routine use of Sanofi and AstraZeneca's Beyfortus to prevent respiratory syncytial virus (RSV) in the US has fallen after it was backed by Centre
The UK's National Institute for Health and Care Excellence (NICE) has said it is minded not to recommend approval of CSL Behring and uniQure's Hemgenix gene therapy for ha
The FDA has rejected Citius Pharmaceuticals' marketing application for Lymphir, an updated version of a lymphoma therapy withdrawn from sale several years ago.
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