US FDA proposes framework to speed rare disease gene therapy approvals

WASHINGTON, Feb 23 (Reuters) - The U.S. Food and Drug Administration proposed on Monday a new framework to speed approvals of ...

US FDA Commissioner Makary says FDA supports mRNA vaccines but US taxpayers should not bear the cost

By Ahmed Aboulenein WASHINGTON, Feb 23 (Reuters) - U.S. Food and Drug Administration Commissioner Marty Makary on Monday defended his agency's position and record on mRNA vaccines, days after it ...

FDA proposes new system for approving customized drugs and therapies for rare diseases

Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to ...

FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...
Yahoo

FDA intends to put its most serious warning on Covid vaccines, sources say

Add Yahoo as a preferred source to see more of our stories on Google. One study estimated that in their first year of use, Covid-19 vaccinations averted almost 20 million deaths around the world. - ...
U.S. News & World Report

Exclusive-US FDA Launches Fresh Safety Scrutiny of Approved RSV Therapies for Infants

Dec 9 (Reuters) - U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their ‌approved protective RSV treatments for infants would face fresh safety ...
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FDA’s new scheme to boost US manufacturing commences despite uncertainty

The US Food and Drug Administration (FDA) will start accepting applications for the new PreCheck scheme that will streamline the introduction of new pharmaceutical manufacturing facilities in the US, ...
U.S. News & World Report

Exclusive-US FDA Brass Pushed Internally for Speedier Lilly Weight-Loss Pill Verdict

Dec 12 (Reuters) - Leaders at the U.S. Food and Drug Administration have pressed internally for reviewers to speed up their evaluation ‌of Eli Lilly's experimental weight‑loss pill, after the company ...
Hosted on MSN

FDA intends to put its most serious warning on COVID vaccines, sources say

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans, the latest move by President Donald Trump’s ...
CNN

US FDA launches fresh safety scrutiny of approved RSV therapies for infants

U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their approved protective RSV treatments for infants would face fresh safety scrutiny following ...