The Department of Justice announces an indictment charging Marina Sievert (Dunedin, FL) with introducing into interstate commerce an unapproved new dr...
FDA updates its device shortage list to remove medical gloves (product codes LYY, LYZ, LZA, and LZC) that were in short supply due to the Covid-19 pan...
FDA announces a 3/28-29/2023 advisory committee meeting to discuss proposed changes to the iPLEDGE Risk Evaluation and Mitigation Strategy for acne dr...
FDA releases two Form FDA-483s after inspecting QuVa Pharma outsourcing facilities in New Jersey and Texas.
Federal Register notice: FDA sends to OMB an information collection extension entitled Improving Communication of Important Safety Information 21 CFR...
FDA grants accelerated approval to Mirati Therapeutics for its Krazati (adagrasib) NDA, indicated for treating adult patients with KRAS G12C-mutated l...
Icelands Alvotech says it expects an FDA decision on its BLA for a Humira biosimilar on 4/13.
FDA warns Pompano Beach, FL-based Empowered Diagnostics about illegally manufacturing and distributing Covid-19 tests.