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Replimune (REPL) Shares Plummet After FDA Rejects Melanoma Drug, Sparking Investor Concerns - Hagens Berman
SAN FRANCISCO, July 23, 2025 (GLOBE NEWSWIRE) -- Investors in Replimune Group, a biotechnology company focused on cancer treatments, witnessed a dramatic collapse in their holdings on July 22. Shares ...
FDA employees say the agency's Elsa generative AI hallucinates entire studies
The federal agency introduced Elsa last month, boasting about the AI tool's ability to increase efficiency at the FDA.
The Well News on MSN6hOpinion
Released FDA Files Show Flawed Drug Approval Process
For decades, the Food and Drug Administration has been notoriously tight-lipped about why it rejects drugs. It has remained ...
What's Going On With Moderna Stock Wednesday?
Moderna stock rises on flu vaccine data and FDA approvals, while healthcare stocks remain under pressure amid political ...
Fierce Pharma7h
FDA delays Blenrep decision, putting GSK's multiple myeloma comeback dreams on ice
Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...
PharmExec7h
FDA Appoints George Tidmarsh as Director of Center for Drug Evaluation and Research
Biotech veteran and Stanford physician-scientist brings 30 years of translational research and regulatory experience to ...
Mother Jones8h
The FDA Held a Misinformation Fest About Antidepressants in Pregnancy
As my colleague Kiera Butler has written, Kennedy has claimed, without evidence, that they can cause addiction and school ...
BioSpace8h
From Expertise to Empty Chairs: The FDA’s Self-Inflicted Crisis
While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...
thederrick.com10h
FDA panel on the use of antidepressants during pregnancy is alarming experts
The U.S. Food and Drug Administration is turning its attention to selective serotonin reuptake inhibitors, a class of antidepressant drugs long criticized by Health and Human Services ...
FDA to review prescription fluoride supplements for kids at risk for tooth decay
The Trump administration is inching closer to banning fluoride tablets and drops often prescribed to kids who don’t have ...
Health and Me on MSN11h
FDA Panel Questions Antidepressant Safety For Pregnant Women; Can SSRIs Harm Unborn Babies?
When the U.S. Food and Drug Administration (FDA) convened a public expert panel to review the use of selective serotonin ...
FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.