FDA Review posts the Federal Register notices for the week ending 7/9/2021.
Federal Register notice: HHS withdraws a 1/21 notice entitled Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importat...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Teva Pharmaceuticals Ajovy (fremanezumab-vfrm),...
St. Jude Medical agrees to pay $27 million to settle allegations under the False Claims Act that it knowingly sold defective heart devices to health c...
FDA and the CDC dismiss the immediate need for Covid-19 booster vaccines in the wake of a Pfizer announcement that the company intends to seek such an...
FDA acting commissioner Janet Woodcock distances herself further from the controversial approval of Biogens Alzheimers therapy Aduhelm (aducanumab-avw...
FDA places a clinical hold on a Sigilon Therapeutics Phase 1/2 study of SIG-001 in patients with severe or moderately severe hemophilia A following a ...
FDA approves Bayers Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart...