FDA to put most serious warning on COVID-19 vaccines

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Health Experts Slam Possible FDA ‘Black Box’ Warning for COVID Vaccines
The FDA is reportedly considering the addition of high-level warning labels to COVID vaccines, a move that some experts say may cause unfounded concerns over safety

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FDA intends to put most serious warning on COVID vaccines, CNN reports
Sources: FDA intends to put ‘black box’ warning on Covid vaccines

FDA, Lilly

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Exclusive - US FDA brass pushed internally for speedier Lilly weight-loss pill verdict
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 pushed for a faster timeline,

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STAT · 13h
Pharmalittle: We’re reading about FDA staff fears, a Lilly weight loss drug and much more
Top FDA brass said to have pushed for a faster review of Lilly’s weight loss pill

sunscreen, FDA and Asia

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FDA proposes allowing sunscreen ingredient already used in Europe and Asia
Bemotrizinol, a broad-spectrum chemical sunscreen ingredient, has long been used abroad. Experts say it offers better protection against both UVA and UVB rays.

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FDA moves to expand sunscreen options, proposing ingredient used in Asia and Europe
New Sunscreen Ingredient Could Soon Be Allowed in the U.S.

FDA approves first at-home device for depression. What is it?

The FDA has approved Flow Neuroscience's at-home brain stimulation device to treat depression, offering an alternative to ...

FDA approves first new antibiotics to treat gonorrhea in decades, with hope to combat drug resistance

For the first time in decades, the US Food and Drug Administration has signed off on new antibiotics to fight gonorrhea. The ...

The FDA Rarely Forces Manufacturers to Recall Dangerous Medical Devices, Watchdog Report Finds

Lawmakers requested the report after a 2023 ProPublica and Pittsburgh Post-Gazette investigation revealed that the FDA had ...

Testosterone levels have declined in men. Here's what the FDA wants to do about it

NPR's Steve Inskeep speaks with FDA Commissioner Martin Makary about the decline in testosterone in men in the U.S. and what ...

Florida, Texas seek to overturn FDA's Mifepristone regulations, claiming mail access undermines state abortion laws

Florida and Texas have filed a lawsuit challenging more than two decades of federal government decisions that cleared the way ...

MO Sen. Josh Hawley pressures FDA chief to limit medication abortion

Hawley and other anti-abortion groups and legislators say the health organization is "slow-walking" a review of the drug ...

FDA approves BioCryst's oral pellet version of swelling disorder drug for children

The U.S. Food and Drug Administration has approved an oral pellet formulation of BioCryst Pharmaceuticals' drug to prevent ...
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CAR-T Developers Will Need Randomized Trials as FDA Eyes Tighter Approval Requirements

For traditional approval, CAR T therapies will need to establish superiority over current standard treatments, including ...