Federal Register notice: FDA withdraws approval of eight ANDAs from multiple applicants after they notified the agency that the drug products were no ...
FDA approves a Kite labeling update to the prescribing information for Yescarta (axicabtagene ciloleucel) to include use of prophylactic corticosteroi...
The Justice Department says whistleblowers will receive about $2.6 million from a $13 million Cardinal Health settlement of charges it violated the an...
CDER releases a list of 98 new and revised draft guidances intended for publication in 2022.
FDA clears a VySpine 510(k) for the ClariVy Cervical IBF System and its use in anterior cervical discectomy with fusion procedures.
FDA says the Empowered Diagnostics recall of more than 250,000 unapproved Covid-19 tests is Class 1.
A Florida federal judge sentences the founder of Blackstone Labs to 54 months in prison and orders him to forfeit $2.9 million for his role in a consp...
Bloomberg News reports that Pfizer/BioNTech are submitting rolling data for an EUA for Covid-19 vaccinations for kids between six months and four year...