FDA to put most serious warning on COVID-19 vaccines

Digest more
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

Continue reading

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

Digest more
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 pushed for a faster timeline,

Continue reading

STAT · 12h
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

FDA, Asia and Europe

Digest more
FDA proposes allowing sunscreen ingredient already used in Europe and Asia
The Food and Drug Administration announced a proposal Thursday to make another sunscreen ingredient available to U.S. manufacturers.

Continue reading

FDA moves to expand sunscreen options, proposing ingredient used in Asia and Europe
FDA considering allowing new sunscreen ingredient in US

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 typical antidepressants.

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

The post The FDA Rarely Forces Manufacturers to Recall Dangerous Medical Devices, Watchdog Report Finds appeared first on ProPublica.

FDA reviewing safety of RSV drugs for infants, no incidents reported

Federal regulators have begun a safety review of two RSV medicines used to protect infants, even though no safety problems ...

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 ...
BioSpace

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 ...