The front page of AI-driven biology
Thursday, October 15, 2026Thu, Oct 15
Updated 7:01 PM PT
The European Medicines Agency's human medicines committee recommended marketing authorization for daraxonrasib, Revolution Medicines' oral RAS inhibitor for pancreatic cancer sold in the United States as Rasonque.
Compass Pathways plans to complete a rolling FDA submission this quarter for COMP360, a synthetic psilocybin therapy for treatment-resistant depression, ahead of a potential launch early next year.
The FDA cleared ImmunityBio's Anktiva, an IL-15 superagonist immunotherapy, for patients with papillary-only non-muscle invasive bladder cancer.
The Food and Drug Administration launched its Rare Disease Framework Initiative to tailor trial requirements and evidence standards to small patient groups.
Physicians and patient advocates raised alarm after Neurocrine Biosciences' Prader-Willi syndrome drug, Vykat XR, was linked to seven patient deaths and nearly 100 hospitalizations since its approval 18 months ago.
The FDA cleared Hovilpri (pritelivir), an oral viral helicase-primase inhibitor, to treat refractory mucocutaneous herpes simplex virus infections in immunocompromised adults failing standard nucleoside therapies.
The FDA will review Roche's intravitreal IL-6 inhibitor vamikibart for uveitic macular edema, setting an action date of July 2027.
The FDA has approved Teva's Weltruza, an extended-release injectable suspension administered once monthly for patients with schizophrenia.
Regulators cleared the oral small-molecule HER2 kinase inhibitor for first-line maintenance in advanced HER2-positive breast cancer in combination with antibody therapies.
The US Food and Drug Administration placed a clinical hold on American sites testing evenamide, Newron Pharmaceuticals' oral voltage-gated sodium channel blocker for schizophrenia, after four patient deaths occurred during the late-stage study.
A patent court in the Netherlands ordered Merck to halt manufacturing and sales of its subcutaneous formulation of pembrolizumab, an anti-PD-1 antibody marketed as Keytruda, across eight European countries including France, Italy, and the Netherlands.
The FDA has granted an expanded indication for remibrutinib, an oral Bruton's tyrosine kinase (BTK) inhibitor marketed as Rhapsido, to treat both of the two most common forms of chronic urticaria.
The Medicines and Healthcare products Regulatory Agency will continually monitor artificial intelligence-based medical devices throughout their lifecycle, replacing the current one-time approval model.
The FDA issued a request for information to guide the design of early-phase clinical trials for ibogaine drug candidates, seeking input on dosing, safety monitoring, care settings, and stopping rules.
The FDA has extended its review period for Novo Nordisk's hemophilia A treatment Frehemgo while manufacturing site corrections are addressed.
FDA Chief Scientist Steven Kozlowski announced that the agency will incorporate aging and longevity research into its upcoming Focus Areas of Regulatory Science report.
An FDA advisory committee has voted that the benefits of Grail's Galleri multi-cancer early detection blood test outweigh its risks, bringing the test closer to premarket approval.
The FDA has accepted Roche's regulatory application to review fenebrutinib, an oral Bruton's tyrosine kinase inhibitor, across two major forms of multiple sclerosis.
The European Commission revoked its marketing authorization for Hansoh Pharma's Aumseqa (aumolertinib), an oral third-generation EGFR inhibitor for non-small cell lung cancer, after a legal challenge by AstraZeneca.
Pierre Fabre Laboratories has resubmitted its biologics license application for Ebvallo, an allogeneic T-cell therapy targeting a complication of Epstein-Barr virus infections that the FDA rejected twice over manufacturing problems.
AstraZeneca and HUTCHMED have submitted a supplemental new drug application to the US FDA for savolitinib, sold as Orpathys, in combination with osimertinib, sold as Tagrisso.
The FDA has approved Roche's anti-CD20 antibody Gazyva (obinutuzumab) for idiopathic nephrotic syndrome, a serious kidney disorder characterized by excessive protein loss in urine.
The FDA cleared tavapadon, marketed as Juvmo, as a once-daily oral selective D1/D5 dopamine receptor agonist for use as a monotherapy or alongside levodopa.
The US Food and Drug Administration has approved AbbVie's therapy for adults with Parkinson's disease, according to the agency's website.
Merck and Daiichi Sankyo have voluntarily withdrawn their application to the FDA for accelerated approval of their experimental lung cancer therapy, patritumab deruxtecan.
The US Food and Drug Administration has approved Mirum Pharmaceuticals' therapy to treat a rare bone condition.
The FDA has expanded the approval of belzutifan (Welireg), Merck's oral HIF-2alpha inhibitor, into second-line therapy for kidney cancer.
The FDA has approved Elevar Therapeutics' targeted therapy Lyrfigtu for the treatment of bile duct cancer, also known as cholangiocarcinoma.
An FDA advisory committee voted 7 to 2, with one abstention, that the benefits of Grail's Galleri multi-cancer early detection blood test outweigh its risks for indicated patients.
The FDA has approved IntraBio's Aqneursa, an orally administered modified amino acid known as levacetylleucine, to treat neurological symptoms in patients with ataxia-telangiectasia.