FDA issues an early alert warning of a potentially high-risk issue involving certain wound and burn dressings made by Integra LifeSciences.
FDA grants Opna Bio an orphan drug designation for its investigational treatment OPN-2853 (zavabresib) for treating myelofibrosis.
A United States Pharmacopoeia study finds that protective purchasing following information on drug shortages can adversely affect access to medication...
FDA releases the form FDA-483 with 10 observations from an inspection at Japans Sato Pharmaceutical over-the-counter drug manufacturing facility.
IntraBio reports positive results from a pivotal Phase 3 clinical trial showing that levacetylleucine significantly improved neurological symptoms in ...
Four drug industry stakeholders say they support an FDA draft guidance proposing to reduce reliance on comparative efficacy studies when determining b...
FDA says it will start accepting applications on 2/1 for its new PreCheck Pilot program intended to boost domestic drug manufacturing capability.
Cogent Biosciences says FDA has agreed to accept the companys planned NDA for cancer drug bezuclastinib under the agencys Real-Time Oncology Review pr...
