CNN

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 ...
Reuters

US FDA approves first at-home device for depression

Dec 11 (Reuters) - The U.S. Food and Drug Administration has approved Flow Neuroscience's at-home brain stimulation device to treat depression, offering an alternative to typical antidepressants that ...
Reuters

Sanofi flags second delay to FDA decision on multiple sclerosis drug, shares fall

Shares drop after FDA delays decision on tolebrutinib drug Late-stage trial shows drug fails to slow disability progression Analysts fret over Sanofi drug pipeline and investor confidence Dec 15 ...
NPR

FDA commissioner on growing public mistrust of government health advice

FDA Commissioner Martin Makary said the government must show greater humility and be more transparent if it hopes to rebuild public trust in its health guidance, which he said has been badly eroded ...
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Atossa Therapeutics stock jumps after FDA grants rare pediatric status to DMD drug — retail bets on phase 3 fast-track

・The FDA designation expands Atossa’s investigational therapy into rare pediatric neuromuscular disease. ・The program could become eligible for a Priority Review Voucher upon future approval.