FDA Approves First Gene Therapy Treatment for Wiskott-Aldrich Syndrome We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok Source link
FDA Approves Acellular Nerve Allograft for Sensory Nerve Repair We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok Source link
FDA Approves First CAR-T Therapy for Relapsed, Refractory Marginal Zone Lymphoma We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok Source link
Chhattisgarh clears over Rs 46 crore for new drug-testing lab and FDA building We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok Source link
The FDA is considering a major change to how new drugs are approved. For decades, the standard has been two solid, well-controlled clinical trials. Now, they’re considering cutting that requirement to just one. It’s being sold as a way to speed things up, to streamline the process and get new medicines to patients faster. On…
Damian Garde is a reporter at large, live and feature journalism, covering the global drug industry and contributing to STAT’s industry-leading events. NEW YORK — Vinay Prasad, the Food and Drug Administration’s top vaccines regulator, blamed “misleading media narratives” for the escalating criticism of his leadership amid turmoil and plummeting morale at the agency. Prasad’s…
When a dozen former FDA commissioners sound the alarm, it’s easy to get lost in the policy debate. But the real story, the one we should be worried about, is the dangerous shift happening inside the agency that’s flying under the radar. The FDA is hemorrhaging its most ethical, science-driven employees—the very people whose job…
WASHINGTON — The Food and Drug Administration plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration for approval, FDA Commissioner Marty Makary told STAT on Wednesday. While historically the FDA has required two trials for added assurance of a drug’s safety and efficacy, it has become increasingly…
WASHINGTON — The Food and Drug Administration removed the longtime director of the office of over-the-counter drugs from her position on Wednesday, six agency sources told STAT. Theresa Michele, director of the Office of Nonprescription Drugs, has worked at the FDA since at least 2015. She told staff in an internal meeting on Wednesday afternoon…
WASHINGTON — Top drug regulator Richard Pazdur has filed papers to retire from the Food and Drug Administration at the end of this month, adding to the turmoil atop the agency. Pazdur informed leaders at the FDA’s drug center of his intention to leave the agency at a meeting on Tuesday, according to two agency…