SpringWorks Therapeutics commences a rolling NDA for mirdametinib, an investigational MEK inhibitor for treating pediatric and adult patients with neu...
CBER cites Oregon Medical Centers in an untitled letter over claims it is making on social media sites Facebook and Youtube about its cellular product...
FDA approves a Boston Scientific PMA for the AGENT Drug-Coated Balloon (DCB), indicated for treating coronary in-stent restenosis in patients with cor...
FDA affirms its regulation of fresh allograft heart valves in a just-posted letter to healthcare professionals.
Endo Health Solutions agrees to plead guilty in federal court and pay over $2 billion in penalties to resolve criminal and civil investigations relate...
FDA declines to grant a hearing request by Vanda Pharmaceuticals on a stalled supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder...
FDA classifies as Class 1 a Datex-Ohmeda recall of its EVair 03 (Jun-air) air compressor (model numbers: 1609000 and 1609002) after the company says i...
FDA approves an Allecra Therapeutics NDA for Exblifep (cefepime/enmetazobactam) for treating complicated urinary tract infections.
