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HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies,...[ Price : $8.95]
FDA denies a petition seeking a partial exemption of 510(k) requirements for some specific radiology computer-aided detection and/...[ Price : $8.95]
Two bipartisan senators press FDA to take a more proactive role in policing prescription drug advertising, citing a surge in misle...[ Price : $8.95]
Ultragenyx Pharmaceutical refiles a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfilip...[ Price : $8.95]
In a wide-ranging 4/1 address to employees at FDA, commissioner Marty Makary outlines an expansive agenda to accelerate drug appro...[ Price : $8.95]
FDA grants full approval for Kites CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or ref...[ Price : $8.95]
CBER publishes a Standard Operating Policy and Procedure on filing an application over protest after a Center refusal-to-file deci...[ Price : $8.95]
CDRH leaders describe efforts to expand the use of real-world evidence in a range of medical device regulatory activities.