Federal Register notice: FDA announces a 2/10/2022 Oncologic Drugs Advisory Committee meeting that will vote on an Innovent Biologics BLA for sintilim...
Federal Register notice: FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the products were no longer ...
Federal Register notice: FDA seeks comments on an information collection revision entitled Expanded Access to Investigational Drugs for Treatment Use....
Pfizer says new data on its Covid-19 oral antiviral drug Paxlovid (nirmatrelvir tablets and ritonavir tablets) show the drug significantly reduced the...
FDA warns Houstons Cooper Institute for Advanced Reproductive Medicine about significant deviations from the regulations for human cells, tissues, and...
FDA issues a guidance modifying REMS requirements for Genentechs Actemra under certain conditions during the Covid-19-related Actemra shortage.
FDA approves two Svelte Medical drug-eluting stent systems.
Federal Register notice: FDA makes available a draft guidance entitled Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Develop...