St. Jude Medical recalls Unify and Unify Assura cardiac resynchronization therapy defibrillators due to battery issues.
FDA warns Swedens Euro Diagnostica about Quality System and Medical Device Reporting violations in its manufacturing of Class 2 medical devices.
FDA warns Diasol about QS violations in its New Jersey manufacturing and repacking facility.
Novo Nordisk asks FDA not to approve any ANDA for a drug referencing any of its liragltide-containing drugs and put restrictions on any NDA citing the...
Pfizer tells FDA that an agency draft guidance on CMC postapproval manufacturing changes for specified biological products may conflict with an existi...
FDA accepts an Allergan NDA for ulipristal acetate, an investigational drug for treating abnormal uterine bleeding in women with uterine fibroids.
FDA issues a complete response letter for Mylans BLA for MYL-1401H, a proposed biosimilar of Amgens Neulasta (pegfilgrastim).
FDA releases its latest batch of Warning Letters that includes Diasol, Euro Diagnostica, Option Care, and Laveeza Bhatti.