The Association for Accessible Medicines urges FDA to continue to revise a draft guidance on pre-submission facility correspondence.
FDA accepts for review a Regeneron Pharmaceuticals supplemental BLA for Dupixent (dupilumab) for treating adults and adolescents aged 12 years and old...
The National Cancer Institute raises concerns about an FDA guidance that requires studies of oncologic investigational agents to enroll additional pat...
An unfavorable interim analysis leads Incyte to discontinue the Phase 3 LIMBER-304 myelofibrosis trial due to efficacy concerns.
FDA clears an Abbott 510(k) for its FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring system sensors for integration wi...
CDER director Patrizia Cavazzoni says the agency is stepping up its actions to prevent contaminated drug products, including cough/cold syrups with di...
Presumably in an attempt to block or delay potential generic Mayzent products, Novartis petitions FDA to make generic versions meet certain requiremen...
FDA accepts for priority review an Eisai and Biogen supplemental BLA for Leqembi (lecanemab-irmb) 100 mg/mL injection that is intended to convert the ...
