Pfizer says it is discussing its plans this week with FDA to seek authorization for a Covid-19 vaccine booster shot.
FDA announces an 11/12 virtual public workshop on orthopedic cartilage repair products that will discuss data and studies needed to support marketing ...
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...