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Regulatory Intelligence & Drug Approvals16 hours 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...
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Regulatory Intelligence & Drug Approvals18 hours agoAbbVie bids to join the BCMA crowd with etentamig
AbbVie has filed for FDA approval of its BCMAxCD3 bispecific etentamig in multiple myeloma, a key pillar of its expansion into oncology.
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Regulatory Intelligence & Drug Approvals1 day agoBiotechs going to market alone must learn to go global
Drug developers increasingly have the option of seeking regulatory approval and commercializing a medicine themselves, rather than accepting an early exit offer. Doing so requires a...
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Regulatory Intelligence & Drug Approvals2 days agoSTAT+: FDA offers new details on quicker approval pathway for personalized gene therapies
Rare disease advocates applauded the FDA's move to speed access to treatments.
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Regulatory Intelligence & Drug Approvals2 days agoSTAT+: Pharmalittle: We’re reading about a Novo setback in court, a House probe into big PBMs, and more
A U.S. judge rejected a bid to block Eli Lilly from running what Novo Nordisk claims is a “deceptive” advertising campaign about weight loss drugs
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Regulatory Intelligence & Drug Approvals2 days agoBest Chinese Medicines LLC – 738556 – 10/23/2026
Unapproved New Drugs
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Regulatory Intelligence & Drug Approvals2 days agoWhat 3 multibillion dollar biotechs still have to prove
Summit, Abivax and Viking have lofty valuations but no FDA-approved products. Each faces a different test of its clinical promise and commercial potential.
Genmab’s cancer bispecific delivers early survival win in ‘exceedingly positive’ Phase 3 readout
Genmab’s cancer bispecific delivers early OS win in ‘exceedingly positive’ Phase 3 readout
STAT+: HHS moves to allow compounding of some unapproved peptides
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
