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Regulatory Intelligence & Drug Approvals2 days agoAdvancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products – 09/10/2026
This half-day virtual workshop features FDA expert presentations and audience Q&A on bioequivalence (BE) approaches for topical and transdermal generic drug products.
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Regulatory Intelligence & Drug Approvals2 days agoFDA approves first treatment for children aged 4-11 years with APDS, a rare genetic disorder of the immune system
FDA has approved Joenja (leniolisib) tablets as the first treatment for activated phosphoinositide 3-kinase delta syndrome in children 4-11 years who weigh at least 27 kg....
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Regulatory Intelligence & Drug Approvals2 days agoAfter FDA nod for novel Cabometyx formulation, analysts predict limited threat to Exelixis
Following formal sign-off from the FDA, Handa Pharmaceuticals’ branded drug reformulation strategy has paid off for a third time.
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Regulatory Intelligence & Drug Approvals2 days agoHengrui gets world-first okay for platelet drug hetrombopag
Hengrui's oral TPO agonist, hetrombopag, is the first in the class to be approved for thrombocytopenia caused by chemotherapy for solid tumours.
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Regulatory Intelligence & Drug Approvals2 days ago
The future of RAS inhibitors
Revolution Medicines recently made history with the approval of its RAS inhibitor Rasonque for advanced pancreatic cancer. But behind RevMed is an entire field of biotechs...
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Regulatory Intelligence & Drug Approvals2 days ago
FDA delays approval decision for Exelixis’ tyrosine kinase inhibitor in colorectal cancer
The FDA has delayed its approval decision for Exelixis’ oral kinase inhibitor in combination with Roche’s Tecentriq for the treatment of metastatic colorectal cancer.
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Regulatory Intelligence & Drug Approvals2 days ago
Selective oestrogen receptor degrader class grows with new cancer approval
Nature Reviews Drug Discovery, Published online: 11 September 2026; doi:10.1038/d41573-026-00151-0Selective oestrogen receptor degrader class grows with new cancer approval
Carbon Dots Emerge as a Powerful Weapon Against Superbugs and Biofilms
Your Zip Code May Shape Your Breast Cancer Tumor’s Genetics and Your Survival Odds
Azithromycin Resistance in Gonorrhea Shifts Genetic Ground, Challenging Molecular Surveillance
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
