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Regulatory Intelligence & Drug Approvals3 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 Approvals3 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 Approvals3 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 Approvals3 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 Approvals3 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
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Regulatory Intelligence & Drug Approvals4 days ago
In first interview as FDA oncology chief, Angelo de Claro vows to ‘continue the innovation’ behind OCE legacy
In his first interview after taking the reins of the FDA’s Oncology Center of Excellence, Angelo de Claro, M.D., is outlining a regulatory agenda that prioritizes...
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Regulatory Intelligence & Drug Approvals4 days agoTips to Stay Safe in the Sun: From Sunscreen to Sunglasses
Sun safety is always in season. It’s important to protect your skin from sun damage throughout the year, no matter the weather. The FDA continues to...
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Regulatory Intelligence & Drug Approvals4 days agoShould You Put Sunscreen on Infants? Not Usually
Your infant’s sensitive skin is vulnerable to serious burns. But sunscreen isn’t the answer. Infants are at greater risk than adults of sunscreen side effects, such...
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Regulatory Intelligence & Drug Approvals4 days agoFDA Rare Disease Innovation Hub
FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of...
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Regulatory Intelligence & Drug Approvals4 days agoDrug Compliance Programs
FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area.
Psychedelic therapies ride wave of public favor into FDA hearing
After a brief storm of political headwinds, mRNA is back with strong momentum
STAT+: Trump’s secretive pharma deals may undermine ‘most-favored nation’ pricing, an analysis suggests
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
