FDA accepts for review an Incyte NDA seeking approval of parsaclisib for treating patients with relapsed or refractory follicular lymphoma, marginal z...
FDA approves an ANI Pharmaceuticals supplemental NDA for purified cortrophin gel (repository corticotropin) for treating certain chronic autoimmune di...
Federal Register notice: FDA withdraws approval of 18 NDAs from multiple applicants because the drug products are no longer marketed.
Moderna says ongoing FDA safety concerns with Modernas Covid-19 vaccine and its potential use in adolescents has led to a filing delay for an emergenc...
Federal Register notice: FDA posts a draft guidance entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the F...
Federal Register notice: FDA seeks public comments on a proposed information collection entitled Text Analysis of Proprietary Drug Name Interpretation...
Datascope/Getinge/Maquet recalls its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs due to a battery failure risk.
An Illinois federal judge sentences a former Aegerion Pharmaceuticals sales rep to 54 months in prison for using the identities of physicians to carry...