-
Regulatory Intelligence & Drug Approvals6 days agoFDA places partial hold on Biohaven’s epilepsy drug
Announced mere weeks after Biohaven sold off rights to the therapy, opakalim, the halt affects a study some analysts believe is necessary to support a potential...
-
Regulatory Intelligence & Drug Approvals6 days agoQuestions and Answers: FDA’s regulatory actions on over-the-counter sunscreen
The following questions and answers provide more information on FDA’s regulatory actions on over-the-counter sunscreen.
-
Regulatory Intelligence & Drug Approvals6 days agoBiohaven takes another hit as FDA pauses enrollment in pivotal trials for embattled epilepsy drug
The enrollment pause comes after BHV-7000 failed to show efficacy in a midstage depression trial late last year. The news is another regulatory hit for Biohaven...
-
Regulatory Intelligence & Drug Approvals6 days agoSTAT+: FDA expands Bayer lung cancer drug approval
UniQure readout tests durability of benefits, an AI effort to manage heart failure, and more biotech news from The Readout
-
Regulatory Intelligence & Drug Approvals6 days agoReviews underway of first drug for rare disease MOGAD
Patients with rare autoimmune disease MOGAD could be months away from having a first approved therapy, as the FDA starts a review of Roche's Enspryng.
-
Regulatory Intelligence & Drug Approvals6 days agoBayer moves Hyrnuo into frontline lung cancer treatment
Bayer chases after Boehringer with an FDA approval for oral HER2 inhibitor Hyrnuo in previously untreated HER2+ lung cancer.
-
Regulatory Intelligence & Drug Approvals7 days agoBiohaven epilepsy drug suffers FDA hold days after attracting $350M deal
The FDA has put enrollment in trials of Biohaven’s epilepsy drug candidate BHV-7000 on hold in response to findings from rodent tests, dealing a blow to...
-
Regulatory Intelligence & Drug Approvals7 days agoFor PDUFA VIII, the most valuable incentive may be time
The FDA’s proposal to offer 50% off application fees for drugs with early-stage trials conducted in the U.S. is unlikely to achieve the intended result. What...
-
Regulatory Intelligence & Drug Approvals7 days ago
Epidural Kit Correction: Medical Action Industries Issues Correction for Epidural Kits Containing Spectra Medical Devices Lidocaine Ampules
Medical Action Industries is correcting epidural kits containing recalled Huons Co. sodium chloride ampules.
-
Regulatory Intelligence & Drug Approvals7 days ago
FDA approves oncolytic virus
Nature Biotechnology, Published online: 10 September 2026; doi:10.1038/s41587-026-03316-9FDA approves oncolytic virus
FDA warning letter accuses Bausch & Lomb of lacking commitment to remediation
Deep dive: Psychedelics back on FDA’s doorstep
‘Patients are not a renewable resource’: Rethinking rare disease R&D
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
