EMA and payers want to know more about daily life improvements from US FDA-approved Duchenne muscular dystrophy treatment.
Sarepta Therapeutics Inc. is developing new patient information to potentially help gain European approval for its Duchenne muscular dystrophy treatment Exondys 51 (eteplirsen) and possibly help make headway with payers.
Controversially granted accelerated approval by FDA in September, Exondys 51 has been submitted to the European Medicines Agency for conditional...
HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
