FDA adds a Boxed Warning to Amgens osteoporosis drug Prolia (denosumab) about increased risk of severe hypocalcemia in patients with advanced chronic ...
Senator Amy Klobuchar (D-MN) sends letters to six pharmaceutical companies Abbvie, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mylan-Viatris,...
FDA approves a Janssen Biotech NDA for Balversa (erdafitinib) for treating certain adult patients with locally advanced or metastatic urothelial carci...
An FDA reinspection of Alvotechs Iceland manufacturing facility results in a Form FDA-483 with one inspection finding.
Federal Register notice: FDA announces a 3/5 Medical Imaging Drugs Advisory Committee meeting to review and discuss a Lumicell NDA for pegulicianine f...
FDA publishes a guidance on enhanced drug distribution security at the package level.
FDA sends Satsuma Pharmaceuticals a complete response letter on its NDA for STS101 (dihydroergotamine nasal powder), an investigational product for th...
Percussionaire recalls its Distal Phasitron, part: S20020, for use with the Percussionaire VDR-4 ventilator control driver due to the potential for th...
