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Regulatory Intelligence & Drug Approvals5 days agoSTAT+: Vertex kidney disease drug scrutinized for infection risk
Ahead of its FDA approval decision on Nov 30, Vertex's kidney disease drug is being heavily scrutinized for infection risk.
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Regulatory Intelligence & Drug Approvals5 days agoSubmit an eCTD v4.0 or Standardized Data Sample to the FDA
Learn more about FDA's process to validate sample new eCTD v4.0 submissions and standardized study datasets.
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Regulatory Intelligence & Drug Approvals5 days agoHHS clears compounding pharmacies to manufacture 6 unapproved peptides
Under the interim policy, officials do not intend to take action against sites that produce the peptides.
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Regulatory Intelligence & Drug Approvals6 days agoFDA Drug Info Rounds Video
A new series of training videos for practicing clinical and community pharmacists
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Regulatory Intelligence & Drug Approvals6 days agoQuality and Regulatory Predictability: Shaping USP Standards – 12/11/2025
This discussion will show how USP public standards strengthen quality, streamline development, support regulatory compliance, and overall, increase regulatory predictability for drugs.
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Regulatory Intelligence & Drug Approvals6 days agoSTAT+: HHS moves to allow compounding of some unapproved peptides
Kennedy and his MAHA movement have embraced peptides, though there's little evidence for many of the wellness compounds.
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Regulatory Intelligence & Drug Approvals6 days agoFDA unveils guidance for ‘plug and play’ gene therapies
The plan builds on recent FDA moves to speed "personalized" treatments by offering an approval framework for therapies benefiting different subsets of patients with the same...
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Regulatory Intelligence & Drug Approvals6 days agoNew FDA draft guidance doubles down on expediting approvals of personalized gene therapies
The FDA has outlined a process for allowing a single application to cover multiple variants of a gene therapy. At the same time, the Centers for...
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Regulatory Intelligence & Drug Approvals6 days agoSTAT+: Pharmalittle: We’re reading about 340B battles, new results for a Lilly weight loss drug, and more
Missouri attorney general warned Eli Lilly to discontinue requiring hospitals to provide claims data to receive discounted medicines under 340B program
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Regulatory Intelligence & Drug Approvals6 days agoLilly’s retatrutide trounces Novo’s Ozempic in diabetes, weight loss
Eli Lilly’s next-gen weight loss drug retatrutide soundly beat Novo’s approved medicine Ozempic in weight loss and blood sugar reduction, padding the case for a regulatory...
RNA-protein interactions could lead to new coronavirus drug targets
A CRISPR gene boost reduces seizures and strengthens muscles in mice
Automated platform optimizes enzyme production using cell-free protein synthesis and AI-driven design
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
