FDA issues a second complete response letter in less than 18 months to Mallinckrodt for its NDA for terlipressin to treat adults with hepatorenal synd...
FDA releases a lengthy FDA-483 with 13 observations from a two-month inspection at Colchester, VT-based Edge Pharma drug outsourcing facility.
Sanofi and GlaxoSmithKline say a Phase 3 trial of their Covid-19 vaccine showed it was 100% effective against severe Covid disease and hospitalization...
AbbVie files a supplemental NDA for Vraylar (cariprazine) for the adjunctive treatment of major depressive disorder in patients who are receiving ongo...
CDER announces a 4/13 Webinar entitled Biosimilars: A Decade of Experience and Future DirectionsStrategies for Improving Biosimilar Adoption and the P...
Baxter International issues an urgent safety communication on upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps.
Ferring petitions FDA to require in vivo testing for ANDA and follow-on applications citing the companys Firmagon as the reference-listed drug.
FDA classifies as Class 1 a recall of the E25Bio Covid-19 Direct Antigen Rapid Test because it has not been authorized, cleared, or approved by the ag...