Biotech archive
Every Biotech story, newest first. 88 in this archive.
Sep 19, 2026
Inductive Beacon 2 Makes Human Dose Computable From Structure Alone
Inductive launched Beacon 2 on 17 September to predict efficacious human dose from chemical structure, reporting a 17 fold improvement in an agentic optimization loop.
Sep 18, 2026
FDA Clears Fayuvi as First Therapy for Pediatric Sanfilippo Syndrome A
Ultragenyx won FDA approval for Fayuvi on 17 September 2026, the first labeled therapy for Sanfilippo syndrome type A in children with preserved neurodevelopmental function, following a prior complete response letter on manufacturing.
Sep 17, 2026
Insilico Publishes LongevityBench and Compact Longevity LLMs in Cell
Insilico Medicine published LongevityBench in Cell on 17 September 2026, releasing 17 aging biology tasks, five compact Longevity LLMs, and an open Longevity Claw research interface.
Sep 16, 2026
Novo Nordisk Tests Claude in Drug Discovery Workflows
Novo Nordisk partnered with Anthropic on 16 September 2026 to deploy Claude and Claude Science inside research and development workflows, signaling that large pharma will treat frontier models as reasoning infrastructure rather than a standalone discovery engine.
Sep 15, 2026
Sponsor RTCT Comments Show AI Enters Trials Through Data Plumbing First
Industry comment letters on FDA real time clinical trials show sponsors want AI in reconciliation and surveillance first, with human review gates on dose and safety decisions.
Sep 14, 2026
FDA Clears Pixclara as First Amino Acid PET Agent for Glioma Imaging
Telix Pharmaceuticals said on 14 September 2026 the FDA approved Pixclara, floretyrosine F 18, as the first amino acid PET imaging drug for glioma, helping distinguish recurrence from treatment related change.
Sep 13, 2026
FDA Expands Sevabertinib to First Line HER2 Mutated Lung Cancer
On 9 September 2026 the FDA granted accelerated approval to sevabertinib for first line treatment of locally advanced or metastatic HER2 mutated non squamous NSCLC.
Sep 12, 2026
Pharming Wins First APDS Label for Children Aged Four Through Eleven
The FDA approved expanded Joenja dosing on 11 September 2026 for children aged four to eleven with APDS who weigh at least 27 kg, making leniolisib the first approved treatment for that pediatric cohort in the United States.
Sep 11, 2026
Scholar Rock Wins FDA Approval for Spinal Muscular Atrophy Therapy
The FDA approved Scholar Rock's therapy for a rare genetic muscle weakness condition on 11 September, giving the company its first commercial product in a neuromuscular market with few options.
Sep 10, 2026
PostEra Sells AI Designed Fertility Programs to EMD Serono in a Platform Exit Test
EMD Serono acquired PostEra's FSHR and LHCGR agonist programs, oral small molecule fertility candidates designed with PostEra's Proton AI platform and still in preclinical development.
Sep 8, 2026
Recursion Clears IND for AI Designed PI3Kα Inhibitor REC 7735
Recursion said the FDA cleared REC 7735, an AI designed PI3Kα H1047R inhibitor, and plans to start the Phase 1/2 ZINNIA trial in the second half of 2026 after a 10 month, 242 compound design cycle.
Sep 7, 2026
FDA Clears Etcamah as First Line Oral SERD for ESR1 Mutated Breast Cancer
FDA accelerated approval of AstraZeneca's oral SERD Etcamah pairs first line ESR1 mutated breast cancer treatment with Guardant360 CDx liquid biopsy testing.
Sep 6, 2026
Ionis Wins FDA Approval for First Alexander Disease Therapy Zanvastro
FDA approved Ionis Zanvastro as the first targeted therapy for Alexander disease, giving the biotech its first independent neurology launch.
Sep 5, 2026
AbbVie Etentamig Hits 74 Percent ORR in Phase 3 CERVINO Myeloma Trial
AbbVie reported on 3 September 2026 that Phase 3 CERVINO met ORR and PFS endpoints for etentamig in triple class exposed myeloma, with 74.0 percent ORR versus 45.7 percent and PFS hazard ratio 0.40. Full results arrive at IMS Glasgow on 25 September.
Sep 4, 2026
BigHat Doses First Patient With an AI Designed CDH17 ADC in Phase 1
BigHat Biosciences dosed the first patient on 1 September 2026 in a Phase 1 study of BHB810, an AI designed CDH17 directed ADC for gastrointestinal cancers. Oncology R&D teams should watch whether developability choices from the platform survive early human safety and pharmacokinetic readouts.
Sep 3, 2026
Ono Pharmaceutical Bets on Causal AI Digital Twins for Neurology Targets
Ono Pharmaceutical partnered with Aitia to use causal AI digital twins for neurology target discovery, granting Ono an exclusive worldwide option on identified candidates. R&D leaders should watch whether option exercises follow within a year.
Sep 2, 2026
Owkin Licenses K Pro and Multimodal Patient Data to Boehringer Ingelheim
Owkin licensed its K Pro AI scientist and fresh multimodal oncology and immunology data to Boehringer Ingelheim, expanding a 2025 spatial biology pilot into a platform scale discovery partnership.
Sep 1, 2026
DnaK and GATC Health Use AI to Rank 16 Oncology Candidates Early
DnaK Therapeutics will use GATC Health's predictive AI to rank 16 oncology candidates before preclinical spend, with initial prioritization results expected this fall.
Aug 31, 2026
Proteina and Twist Pair AI Antibody Design With High Volume Wet Lab Proof
Proteina and Twist Bioscience agreed on 27 August 2026 to pair AI designed antibody libraries with large scale synthesis and wet lab validation, targeting a defined collaboration model by year end.
Aug 30, 2026
Noetik Hits First GSK Milestone After Deploying OCTO VC Cancer Models
Noetik hit the first GSK milestone after deploying OCTO VC cancer foundation models for virtual cell work and patient stratification under a 50 million dollar upfront licensing deal.