FDA approves PharmaThers KETARx (ketamine), indicated for use in treating surgical pain.
FDA orders significant labeling changes for Bluebird Bios Skysona (elivaldogene autotemcel), a gene therapy approved for treating early, active cerebr...
FDA says a nationwide shortage of sodium chloride 0.9% injection products has officially ended.
Becton Dickinson recalls (Class 1 device correction) its BD Alaris Pump Module Model 8100 with Guardrails, Suite MX software versions.
FDA grants Boehringer Ingelheim accelerated approval for Hernexeos (zongertinib), a kinase inhibitor for treating certain adults with unresectable or ...
FDA expands its drug quality enforcement efforts since the end of the Covid-19 Public Health Emergency, with foreign oversight reaching all-time highs...
FDA lifts an earlier recommended pause on the use of Valnevas Ixchiq vaccine for chikungunya virus.
FDA says it is starting the FDA PreCheck program to help drug companies develop manufacturing facilities in the U.S.
