The Food and Drug Administration has one job that matters above all others: keep unsafe drugs off the market and ensure that the medications Americans take actually work. For decades, despite legitimate criticisms about speed and bureaucracy, the agency maintained a reputation for scientific rigor that made FDA approval the global gold standard. That foundation…
The recent news that the head of the Food and Drug Administration’s drug reviewing division had been ousted showed a federal health administration in chaos. Yet a peek behind the main storyline reveals that something more troubling is happening. The Trump administration is turning drug review into make-a-deal. A new voucher program has created procedurally…
FDA Clears CUSA Clarity Ultrasonic Surgical Aspirator for Cardiac Procedures 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
There’s a quiet but troubling shift happening in the halls of biotech companies right now, and it’s not getting nearly the attention it deserves. While the FDA grapples with leadership gaps, budget constraints, and an overloaded review calendar, some biotech executives see the chaos not as a regulatory risk—but as an opportunity. They’re treating FDA…
New warnings and restrictions placed on Sarepta Therapeutics’ gene therapy last week by the Food and Drug Administration have cast a spotlight on an important, but overlooked heart-safety risk. “Acute, serious, and life-threatening” cases of heart inflammation called myocarditis and elevations of troponin-I, a protein released by dying heart-muscle cells, have been reported in patients…
FDA Approves IV Fosfomycin for Complicated UTIs 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
In recent years, the pharma industry has been navigating not only the usual pressures of launching new drugs, managing lifecycle strategies, and dealing with digital transformation, but also a shifting regulatory environment at the Food and Drug Administration (FDA). The question we’ll examine here: Is pharma “pushing the envelope” on regulatory boundaries because the FDA is…
WASHINGTON — Health secretary Robert F. Kennedy Jr. has said he does not want to take vaccines away from Americans. But at a closed-door meeting of Food and Drug Administration vaccine scientists in September, a top official suggested doing just that. Scientists listened as Tracy Beth Høeg, a lieutenant to FDA Commissioner Marty Makary, laid…
WASHINGTON — The Food and Drug Administration named Richard Pazdur, its longtime overseer of cancer therapies, as top drug regulator on Tuesday. Pazdur replaces former Center for Drug Evaluation and Research Director George Tidmarsh, who exited the agency earlier this month amid accusations of using his regulatory authority to advance a personal vendetta against a…
WASHINGTON — Health secretary Robert F. Kennedy Jr. and many top deputies are scheduled to speak alongside industry executives and health activists at a daylong MAHA event on Wednesday that has not been publicly disclosed by administration officials or event organizers. The event, called the MAHA Summit, is to take place at the gilded Waldorf…
