Tag Archives: FDA

Facebook Tweet Email Link FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from public scrutiny. The agency “would like to get away” from assembling panels of experts to examine and vote on individual drugs, because “I don’t think …

FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from public scrutiny. The agency “would like to get away” from assembling panels of experts to examine and vote on individual drugs, because “I don’t think they’re needed,” said George …

Starting next week, Apple’s new hypertension notification feature will be coming to Watch Series 9 and later and Apple Watch Ultra 2 and later with the launch of watchOS 26. That’s according to an emailed statement from Apple spokesperson Zaina Khachadourian saying the feature that monitors blood pressure has been cleared by the FDA. Apple’s new hypertension notifications — announced …

Apple Inc. said its hypertension detection system for its smart watch will arrive next week after receiving clearance Thursday from the US Food and Drug Administration. The feature, which was announced at Apple’s most recent product launch event in early September, will be available in 150 countries and regions, including the US, Hong Kong and the European Union. The company …

When Apple announced the new Apple Watch Series 11 and Apple Watch Ultra 3 this week, it unveiled its latest health feature: hypertension notifications. At the time, the company said it expected clearance from the Food and Drug Administration in the United States “soon.” As of Thursday night, that clearance has officially been granted, and the hypertension notifications feature is …

U.S. Marshals and other federal agents, including from the Food and Drug Administration, raided a facility in Bensenville, Illinois, Wednesday morning, that distributes vaping products.  U.S. Attorney General Pam Bondi said the Midwest Goods, Inc. facility on Foster Avenue in the west suburb was one of several facilities raided across the country at the same time today for distributing flavored …

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How do you get COVID-19 booster shots in Florida? FDA decision leads to anger, confusion  Orlando Sentinel For some, Medicare isn’t covering the updated Covid vaccine yet  NBC News What To Know About The New Updated Covid Vaccines For 2025-2026  Forbes CVS Health, Walgreens shift COVID vaccine policies as providers say new FDA criteria create barriers for patients  Fierce Healthcare Think you’re ineligible for …

WASHINGTON — Food and Drug Administration Commissioner Marty Makary said the agency is conducting an “intense investigation” into whether Covid-19 vaccines have caused deaths in children.  In an interview with CNN’s Jake Tapper, Makary said his staff is looking into deaths of young healthy children from the Covid vaccine. He did not share specific data linking pediatric deaths to the vaccine, …

FDA moves to publish drug rejection letters in real time, releases new batch including Replimune’s high-profile snub  Fierce Biotech FDA Drops Another Cache of Heavily Redacted Rejection Letters, Promises Future ‘Real-Time’ Access  BioSpace In a first, FDA publishes complete response letters for ongoing drug applications  Endpoints News MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-assisted Therapy  Yahoo Finance In major …