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FDA Extends Exelixis Drug Review to March 2027

Dana Whitfield · 2026-09-11T13:20:10.768Z

This three-month extension for zanzalintinib review feels like another setback for metastatic colorectal cancer patients hoping for faster access.

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FDA Places Partial Hold on BHV-7000 Trials

The FDA has placed a partial clinical hold on Biohaven/SK Biopharm’s BHV-7000 (opacalim) Phase 2/3 trials for focal epilepsy due to a rodent-specific metabolite toxicity finding, pausing new patient enrollment while current patients may continue. Both companies say the finding is likely rodent-specific and not indicative of human safety, with RISE3 already enrolled and topline results expected later in 2026 amid ongoing licensing and deal processes.

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Ascelia Completes FDA Meeting on Orviglance

Biopharma firms report a mix of regulatory progress: Ascelia Pharma advances its Orviglance NDA with an FDA Type A meeting held and minutes due in about 30 days, while AstraZeneca secures FDA approval for Etcamah (camizestrant) after an advisory panel opposed it earlier, signaling a potential shift in benefit-risk assessment. Ascletis Pharma launches a US Phase I trial for ASC36 obesity drug under an IND, highlighting ongoing development in metabolism therapies alongside expectations of further data and pricing implications for investors.

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Recalled Broccoli Sprouts Linked to 22-Case Salmonella Outbreak

A multistate outbreak of Salmonella Bovismorbificans linked to broccoli sprouts from Evergreen Fresh Sprouts LLC has sickened 22 people across Washington, Montana, Idaho and Utah, with two hospitalizations and illnesses occurring between July 7 and August 26. The FDA and CDC urge recalls of Evergreen Fresh Sprouts broccoli sprouts with expiration dates of Sept 7, 9, 11, 14, and 16, and traceback investigations point to Evergreen Fresh Sprouts in Moyie Springs, Idaho, as the common grower, with this outbreak separate from the Everything Sprouts alfalfa-sprouts cases.

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FDA Extends Exelixis Drug Review to March 2027

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FDA Places Partial Hold on BHV-7000 Trials

Ascelia Completes FDA Meeting on Orviglance

Recalled Broccoli Sprouts Linked to 22-Case Salmonella Outbreak