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FDA commissioner Marty Makary shares his expansive vision for future medical breakthroughs, telling agency staff he hopes to see t...[ Price : $8.95]
FDA says beginning 10/1 it will require drugmakers and other regulated entities to adopt updated international data standards for ...[ Price : $8.95]
FDA grants Context Therapeutics a fast-track designation for its experimental therapy CTIM-76 for treating platinum-resistant ovar...[ Price : $8.95]
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...