Bristol-Myers Squibb says it has resolved manufacturing constraints that led to global supply challenges for Abraxane for injectable suspension.
FDA clears a Cutera 510(k) for AviClear, a laser treatment for mild, moderate, and severe acne.
Ongoing FDA concerns about PI3K inhibitors prompts the agency to discourage MEI Pharma and Kyowa Kirin from seeking accelerated approved of a BLA for ...
The House Oversight and Reform committee asks FDA for answers to what regulatory enforcement actions it sought against Medtronics troubled HeartWare V...
The Senate passes the Cannabidiol and Marijuana Research Expansion Act that is intended to ensure that research on cannabidiol and other potentially b...
FDA amends a GlaxoSmithKline and Vir Biotechnology Emergency Use Authorization for sotrovimab because the 500mg therapy is unlikely to be effective in...
CDERs Office of Prescription Drug Promotion proposes to conduct a study entitled Accelerated Approval Disclosures on Direct-to-Consumer (DTC) Prescrip...
Federal Register notice: FDA withdraws approval of a Secura Bio NDA for Farydak (panobinostat) capsules after the company requested the action because...