Sen. Bernie Sanders and Rep. Peter DeFazio introduce a rule to require federal agencies to negotiate fair pricing agreements with companies producing ...
Four stakeholder groups praise FDA efforts in publishing the Biosimilar User Fee Agreement Statement of Work before the 10/1 anticipated agreement app...
FDA grants Bristol-Myers Squibb accelerated approval for Opdivo (nivolumab) for treating certain patients 12 years and older with mismatch repair defi...
FDA approves Celgenes Idhifa (enasidenib) for treating adult patients with relapsed or refractory acute myeloid leukemia who have a specific genetic m...
FDA clears an Immunalysis 510(k) for the Sefria Fentanyl Urine Enzyme Immunoassay for the qualitative detection of fentanyl in urine.
FDA Webview editor Jim Dickinson analyzes a Washington Post article on the Essure contraceptive device and sees an ingrained pattern of ossified CDRH ...
FDA grants AstraZeneca and MedImmune a breakthrough therapy designation for Imfinzi (durvalumab) for treating patients with locally-advanced, unresect...
Amgen files a supplemental BLA for Prolia (denosumab) for treating patients with glucocorticoid-induced osteoporosis.