inspection

Catalent Bloomington Indiana facility

Moderna booster supply resumed after FDA cites Catalent plant

After withholding millions of Moderna’s COVID booster doses because of manufacturing issues at a Catalent factory, the U.S. has released the shots.

Kevin Dunleavy Sep 21, 2022 11:23am

stop sign

Spectrum's Rolontis has been hit with an FDA complete response

Aug 6, 2021 9:30am

coronavirus vaccine

AZ's India vaccine partner may help deliver doses to Europe

Feb 16, 2021 8:19am

Hanmi

Spectrum's Rolontis delayed amid COVID-19 travel restrictions

Oct 27, 2020 8:49am

FDA

FDA will resume domestic inspections despite COVID-19 uptick

Jul 13, 2020 11:30am

FDA

FDA looks to restart inspections delayed by COVID-19

May 14, 2020 8:55am