All articles tagged with #fda panel
Replimune’s RP1 melanoma immunotherapy saw its shares jump about 107% after a FDA advisory committee voted 10-3 that the study results were valuable and clinically meaningful, a boost for accelerated approval prospects despite prior BLA denials in 2025; analysts subsequently upgraded the stock.
The article criticizes an FDA panel for exaggerating the risks of antidepressant use during pregnancy, highlighting the importance of maternal mental health and the author's personal experience of safely continuing medication during pregnancy, arguing that such misinformation could hinder women’s access to necessary treatment.
A recent FDA panel raised concerns about the safety of SSRIs during pregnancy, but many doctors and health organizations argue that the panel's claims are misleading and based on poor-quality evidence, emphasizing that most SSRIs are safe and that untreated mental health issues pose significant risks to both mother and baby.
An FDA panel's discussion on antidepressants during pregnancy was criticized by psychiatrists for spreading misinformation and lacking balance, with some panelists emphasizing unproven risks and questioning drug efficacy, despite medical consensus supporting the safety and importance of SSRIs for pregnant women with depression.