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 says it will allow up to 12 months for doctors to transition patients who are taking unapproved animal-derived thyroid medications to approved syn...
Eli Lilly says it will file an NDA by the end of the year for its investigational obesity treatment orforglipron, based on just-announced Phase 3 data...
