FDA actions, approvals, policy shifts, and compliance—how rules change timelines and probability.
The U.S. Food and Drug Administration has asked Eli Lilly to provide further cardiovascular and liver safety data on its new obesity medication, Foundayo, following reports of serious safety signals.
The U.S. Food and Drug Administration has asked Eli Lilly to provide further cardiovascular and liver safety data on its new obesity medication, Foundayo, following reports of serious safety signals.
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Despite a Phase 3 study where it was outperformed by Sanofi’s Avapro, Travere Therapeutics' Filspari has received FDA approval as the only treatment available for focal segmental glomerulosclerosis.
The FDA’s policy to publish complete response letters (CRLs) has increased transparency surrounding drug approval rejections and encouraged biopharma companies to be more detailed in their disclosures.
The FDA’s approach to regulatory flexibility, particularly concerning rare diseases, is evolving, resulting in both opportunities and challenges for biopharma companies.
A 2027 budget proposal from President Donald Trump has sparked significant concern among healthcare policy experts due to deep cuts in healthcare funding.
The U.S. Department of Justice is increasing scrutiny on hospital contracting practices, targeting tactics that reduce competition and sustain high healthcare costs through exclusive agreements.
A STAT reader questions whether the perceived lack of nutrition education in medical school is the true issue in prevention care.
Sports betting is increasingly recognized as contributing to a twofold public health crisis, especially impacting young men with addictive and compulsive behaviors.
The FDA has once again issued a complete response letter rejecting Replimune’s melanoma drug RP1, citing continued concerns over the single-arm trial used in support of its approval.
GSK has once again pulled its regulatory application for leucovorin, a drug the FDA previously highlighted for its potential in treating autism associated with cerebral folate deficiency.
The FDA has been instructed by a Louisiana court to complete a fresh review on the safety of mifepristone while mail distribution for the pregnancy pill continues pending investigation updates.
