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Regulatory Intelligence & Drug Approvals1 month agoWhere does FDA nominee Overton stand on vaccines and other key pharma issues?
Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on vaccine-related decisions and work to speed early drug...
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Regulatory Intelligence & Drug Approvals1 month agoFDA nominee Overton parries vaccine questions at Senate hearing
Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on key decisions and work to speed early drug...
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Regulatory Intelligence & Drug Approvals1 month agoSTAT+: FDA commissioner nominee Heidi Overton keeps opinions to herself in Senate hearing
Senators focused on asking Overton about vaccines, abortion, and vapes.
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Regulatory Intelligence & Drug Approvals1 month agoFDA Approves Onswik (insulin efsitora alfa-gobe) Once-Weekly Basal Insulin for Adults with Type 2 Diabetes
INDIANAPOLIS, Sept. 24, 2026 /PRNewswire/ -- Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) approval of Onswik™ (insulin efsitora alfa-gobe), a...
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Regulatory Intelligence & Drug Approvals1 month agoThe FDA’s Overton era, and dispatches from Shanghai
The Readout LOUD is going international this week with a dispatch from Shanghai, along with notes on the FDA's Overton era.
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Regulatory Intelligence & Drug Approvals1 month agoFDA approves belzutifan in combination with lenvatinib for advanced renal cell carcinoma with a clear cell component
On September 24, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with lenvatinib (Lenvima, Eisai Inc.) for adults with...
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Regulatory Intelligence & Drug Approvals1 month ago
FDA slams GLP-1 compounder over risk of contaminating drugs ‘with filth’
FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly’s tirzepatide and Novo’s semaglutide “regularly or in inordinate amounts” at a site...
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Regulatory Intelligence & Drug Approvals1 month agoUS senators grill FDA nominee Overton on ability to ‘stand up’ to Trump
In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as...
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Regulatory Intelligence & Drug Approvals1 month agoPublic Meeting on Patient-Focused Drug Development for Long COVID – 04/25/2023
On April 25th, 2023, FDA is hosting a virtual public meeting on Patient-Focused Drug Development for Long COVID. This meeting will provide FDA the opportunity to...
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Regulatory Intelligence & Drug Approvals1 month agoTrump’s FDA pick Heidi Overton calls vaccines, mifepristone safe and effective in confirmation hearing
The Senate Committee on Health, Education, Labor and Pensions (HELP) today questioned Heidi Overton, M.D., Ph.D., Trump’s pick for FDA commissioner, in a hearing marked by...
Opentrons Raises $40M in Series E to Expand Its Robotics, Software, Data Infrastructure
100 Million-Cell AI-Ready Dataset with Single-Cell and Proteomic Data Created by Parse and Nomic
No Nonsense: David Liu Lauds Progress in Disease-Agnostic Gene Editing at ESGCT
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
