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.
FDA accepts for review a Pfizer NDA for etrasimod to treat some patients with ulcerative colitis.
Celltrion USA submits a BLA to FDA for a novel subcutaneous formulation of its infliximab to be used as maintenance therapy in some ulcerative colitis...
FDA warns Camarillo, CA-based Green Pharmaceuticals that it is distributing an adulterated unapproved new drug.