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Regulatory Intelligence & Drug Approvals6 days agoFDA clears Bayer’s Hyrnuo in first-line lung cancer, amping up Hernexeos rivalry
Bayer has won first-line approval for its tyrosine kinase inhibitor, Hyrnuo, in patients with HER2-mutant non-small cell lung cancer. The green light comes around half a...
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Regulatory Intelligence & Drug Approvals6 days agoFDA gains ‘continuity’ as Mikhail, Davis named permanent CBER, CDER leaders
After almost two years of turnover in the FDA’s top ranks, the new appointments should help ease concerns about more turmoil ahead, one analyst said.
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Regulatory Intelligence & Drug Approvals6 days agoFDA-TRACK: Expanded Access (Compassionate Use) Submission Data
FDA-TRACK: Expanded Access (Compassionate Use) Submission Data
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Regulatory Intelligence & Drug Approvals6 days agoSTAT+: Orexin discoverers awarded prestigious Lasker award
A new FDA CBER head, AI company Schrodinger with a new startup, and more biotech news from The Readout
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Regulatory Intelligence & Drug Approvals6 days agoSTAT+: Pharmalittle: We’re reading about an AstraZeneca COPD win, the FDA filling key jobs, and more
An AstraZeneca drug reduced the dangerous flare-ups that worsen COPD in a pair of late-stage trials
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Regulatory Intelligence & Drug Approvals6 days agoFDA gains ‘continuity’ as Mikhail, Davis named permanent CBER, CDER leaders
After almost two years of turnover in the FDA’s top ranks, the new appointments should help ease concerns about more turmoil ahead, one analyst said.
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Regulatory Intelligence & Drug Approvals6 days agoActing CBER, CDER heads become permanent as FDA works to restore stability
The decision to promote Michael Davis and Karim Mikhail from acting to permanent division heads comes as the FDA awaits the potential confirmation of Heidi Overton,...
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Regulatory Intelligence & Drug Approvals6 days agoFDA starts review of AZ’s COPD blockbuster hope
The FDA has started a priority review of AstraZeneca's first-in-class IL-33 inhibitor tozorakimab for COPD, setting up a decision in Q1 of 2027.
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Regulatory Intelligence & Drug Approvals6 days agoFDA makes acting CDER, CBER chiefs permanent
Michael Davis becomes the permanent head of CDER, while Karim Mikhail is confirmed as permanent CBER director and the FDA names its first AI leader.
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Regulatory Intelligence & Drug Approvals6 days agoFDA grants RMAT designation to RiboX’s RXRG001 for xerostomia
RXRG001 is a circular ribonucleic acid (RNA) therapy encoding human aquaporin-1, a protein involved in fluid transport. The therapy is encapsulated within lipid nanoparticles and directly...
Ensuring safety and accountability in China’s biomedical translation system
Blood centers can help biopharma scale cell and gene therapies
Psychedelics at FDA, Mike Davis’ CDER and translating tRNAs — a BioCentury podcast
Scientists turn pig semen extract into eye drops that kill cancer in mice
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
