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.
FDA warns Stanton, CA-based Sanitor about CGMP and other violations in its manufacturing of misbranded unapproved new drugs.
FDA warns Port Washington, NY-based DeVilbiss Healthcare about Quality System regulation violations in the firms manufacturing of oxygen concentrators...