FDA publishes an interim policy delaying regulatory action on drug compounding using bulk drug substances while the agency develops a required list of...
FDA grants one provision in a Provepharm petition asking for restrictions on the approval of ANDAs or NDAs citing ProvayBlue as the reference-listed d...
FDA approves Novartis Fabhalta to treat adults with paroxysmal nocturnal hemoglobinuria.
Rep. Andy Harris calls for an investigation to determine whether an FDA cozy relationship with the drug industry led to a 10-year delay in acting agai...
Arcutis asks FDA to restrict approvals of any ANDA citing its Zoryve psoriasis cream as the reference-listed drug.
FDA opens its eSTAR electronic submission template for voluntary use for certain PMA submissions.
CBER director Peter Marks outlines his Centers plans to speed gene therapy development, such as through FDA-encouraged harmonization of manufacturing ...
FDA accepts for priority review a Bristol Myers Squibb (BMS) supplemental BLA for Opdivo (nivolumab) for combination use with cisplatin-based chemothe...
