FDA issues Johnson & Johnson a complete response letter for its supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in a quadrup...
FDA approves an Instylla PMA for its Embrace Hydrogel Embolic System, a liquid embolic device for treating hypervascular tumors in peripheral arteries...
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...
FDA issues an early alert based on a Boston Scientific letter to customers about certain Endotak Reliance defibrillation leads that may impact shock e...
FDA issues an alert after Boston Scientific notified customers that all lots of certain Watchman Access Systems have updated use instructions to preve...
An FDA Early Alert says Medline ReNewal recommends that some reprocessed St. Jude electrophysiology catheters be quarantined due to the possibility th...
FDA grants accelerated approval for Jazz Modeyso to treat diffuse midline glioma.
