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Regulatory Intelligence & Drug Approvals1 month agoSTAT+: How a young doctor rose from rural New Mexico to FDA commissioner nominee
What to know about Dr. Heidi Overton, Trump's pick to run the FDA, including her medical background and career trajectory.
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Regulatory Intelligence & Drug Approvals1 month agoConvenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride Ampules
BD is correcting convenience kits and procedural trays containing recalled Huons Co. sodium chloride ampules
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Regulatory Intelligence & Drug Approvals1 month agoHeart Pump Controller Recall: Abiomed Removes Automated Impella Controllers
Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support.
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Regulatory Intelligence & Drug Approvals1 month agoFDA Approves Lyrfigtu (lirafugratinib) for the Treatment of Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement
FORT LEE, N.J., September 23, 2026 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating...
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Regulatory Intelligence & Drug Approvals1 month agoSTAT+: Nominee to lead FDA aims to speed up medical research, combat China’s rise
Exclusive: Heidi Overton plans to tell senators she will speed up biomedical research, working with FDA staff.
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Regulatory Intelligence & Drug Approvals1 month agoSTAT+: FDA advisory panel endorses Grail blood test for cancer, saying benefits outweigh risks
An FDA advisory panel has endorsed Galleri, a blood test designed by the biotech firm Grail to screen for multiple types of cancer.
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Regulatory Intelligence & Drug Approvals1 month agoNovartis bets up to $900M for radioligand therapy from China’s BoomRay
Novartis is the current radiopharma leader with two FDA-approved therapies in Pluvicto and Lutathera.
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Regulatory Intelligence & Drug Approvals1 month agoSTAT+: Drugmakers, biotech VCs show ‘reinvigorated’ interest in osteoporosis treatments
Medicines for osteoporosis are grabbing the attention of the pharma industry, which has been incentivized by a long-awaited regulatory change.
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Regulatory Intelligence & Drug Approvals1 month ago
FDA Approves Bravnetsa (lutetium Lu 177 dotatate) as a Therapeutic Equivalent to Lutathera for the Treatment of Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors in Adults
BEDFORD, Mass., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. ("Lantheus" or the "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to...
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Regulatory Intelligence & Drug Approvals1 month agoCompass vows to press on with FDA application despite new trial request
Citing the urgent unmet need for patients with advanced biliary tract cancer, Compass Therapeutics will continue to seek an approval path for its drug after the...
LncRNA SBF2-AS1 Worsens Heart Injury After Attack via miR-149-5p/PHLPP2 Axis
Stigmatizing language found in over half of primary care patient records
Research report: The Influence of Renal or Hepatic Impairment on the Pharmacokinetics of Iclepertin (BI 425809): Results from Two Phase I Open-Label, Non-randomised, Single Dose, Parallel Design Studies
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
