FDAs Oncologic Drugs Advisory Committee offers a split vote on whether UroGen Pharmas NDA for mitomycin intravesical solution demonstrated a favorable...
Zynex files a 510(k) for its NiCO, Noninvasive CO-Oximeter device that relies on the companys laser technology.
FDA publishes 34 new and 14 revised product-specific guidances to aid in generic drug development.
FDA names Elizabeth Miller acting associate commissioner of the Office of Inspections and Investigations (OII), replacing Michael Rogers, who retired ...
The CDER Office of Prescription Drug Promotion warns Sarfez Pharmaceuticals that promotional materials for its Soaanz edema drug contain false and mis...
FDA commissioner Marty Makary and CBER director Vinay Prasad outline a new regulatory framework for annual Covid-19 booster shots and call for new cl...
The Antidepressant Coalition for Education petitions FDA to change labeling for selective serotonin reuptake inhibitors and serotonin-norepinephrine r...
FDA expands its approval of Bayers Jivi for the routine prophylactic treatment of hemophilia A in previously treated adult and pediatric patients aged...
