No use of the drug has received FDA approval as it can result in serious harm or death, Makary clarified. He emphasized the public must address the trend before it becomes the latest example of ...

(NASDAQ: STIM), a vertically integrated, commercial stage, medical technology and healthcare company with a strategic vision of transforming the lives of patients whenever and wherever they need help, ...

The FDA and CDC will no longer recommend annual COVID vaccinations for healthy people younger than age 65, overturning past official U.S. health policy. “I couldn’t be more pleased to announce ...

The FDA stressed that this is not considered a replacement for the company’s existing shot but can be considered as a second option. Moderna’s new COVID-19 vaccine, named mNexspike ...

(RTTNews) - As May draws to a close, it's time to turn our attention to the FDA's upcoming slate of decisions. From January through May 2025, the U.S. regulatory agency has approved 13 novel drugs ...

The FDA will stop annual COVID vaccines for many people under age 65 this fall. Eligibility will be tied to specific medical conditions like asthma, HIV and pregnancy. Vaccines remain free for ...

The FDA has slapped a clinical hold on Rocket Pharmaceuticals’ pivotal gene therapy trial in response to a death. Rocket, which was aiming to report data in mid-2026, dropped its targeted trial ...

US Food and Drug Administration (FDA) advisers recommended that manufacturers make no changes to the COVID-19 vaccine that will be available for boosters later this summer. The Vaccines and ...

May 27 (Reuters) - The U.S. FDA has paused Rocket Pharmaceuticals' (RCKT.O), opens new tab mid-stage gene therapy trial after a patient died from serious complications, the drug developer said on ...

The FDA will be reviewing new booster shot applications under the new standards laid out by Makary and Prasad, which allow immune data to support clearances in older adults or in those with health ...