An advocacy group takes aim at FDA, arguing in a new report that the agencys drug review process has grown more costly and restrictive.
Kodiak Sciences says its anti-VEGF therapy Zenkuda (tarcocimab tedromer) hit the mark in a second Phase 3 trial in diabetic retinopathy.
Health experts breakdown a new FDA policy framework that could mark a turning point for highly individualized genetic medicines.
FDA warns Bethesda, MD-based Longhorn Vaccines and Diagnostics about Quality System, Medical Device Reporting, and Adulterated and Misbranded Device v...
FDA asks to look at Rezolutes Phase 3 data after the companys trial of ersodetug missed the primary endpoint, with the hope of charting a clear path f...
Quoin Pharmaceuticals says FDA has signaled openness to a streamlined development path for its rare disease candidate QRX003, indicating that a single...
Beam Therapeutics says it will advance its base-editing therapy BEAM-302 into pivotal development to seek accelerated approval for treating Alpha-1 An...
FDA releases the form FDA-483 issued following an inspection at the Micro Labs drug manufacturing facility in Bengaluru, Karnataka, India.
