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Regulatory Intelligence & Drug Approvals6 days 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 Approvals6 days agoFDA grants orphan drug status to Octant’s OCT-980 for RP
The regulatory status specifically includes rhodopsin-associated autosomal dominant retinitis pigmentosa (RHO-adRP), the indication for which the candidate is presently being evaluated. Orphan status is granted to...
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Regulatory Intelligence & Drug Approvals6 days agoArrowhead gains UK marketing authorisation for Redemplo
Concurrently, the National Institute for Health and Care Excellence (NICE) has published Technology Appraisal guidance recommending funding for the National Health Service (NHS) for adult patients...
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Regulatory Intelligence & Drug Approvals6 days 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 Approvals7 days agoFDA Approves Lucamzi (ranibizumab-blrz), a Biosimilar to Lucentis
Solna, Sweden 27 October 2026 – Lucamzi™ (ranibizumab-blrz) biosimilar to Lucentis® has been approved by FDA in the US. Xbrane will finalize preparation for an upcoming...
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Regulatory Intelligence & Drug Approvals7 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 Approvals7 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 Approvals7 days agoBest Chinese Medicines LLC – 738556 – 10/23/2026
Unapproved New Drugs
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Regulatory Intelligence & Drug Approvals7 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.
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Regulatory Intelligence & Drug Approvals1 week agoWoodcock: New paradigm needed to unlock therapies for rare diseases
BIOCENTURY | GUEST COMMENTARYWOODCOCK: NEW PARADIGM NEEDED TO UNLOCK THERAPIES FOR RARE DISEASESFive reforms could make individualized therapies commercially viable — using authority FDA already has
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
