
Revolution Medicines' Rasonque (daraxonrasib) wins FDA approval for second-line pancreatic ductal adenocarcinoma, targeting RAS | Gif: bigbrotherafterdark on Giphy
All the top Biotech & Pharma news in one daily newsletter.
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✅ The Good News ✅
THE GOOD
Approvals & Labels
FDA clears Abbott's Libre Duo 10 Day wearable sensor for glucose and ketone monitoring in diabetes
Medical device, metabolic, continuous glucose monitoring, diabetic ketoacidosis, type 1 diabetes, SGLT2 inhibitors - Read more
Roche wins expanded FDA clearance for HER2 diagnostics tied to Jazz Pharmaceuticals' Ziihera in metastatic gastroesophageal adenocarcinoma
Antibody, cancer, antibody-drug conjugate, gastric cancer, HER2, companion diagnostic - Read more
Revolution Medicines' Rasonque (daraxonrasib) wins FDA approval for second-line pancreatic ductal adenocarcinoma, targeting RAS
Small molecule, cancer, RAS inhibitor, pancreatic cancer, non-small cell lung cancer, KRAS - Read more
ViiV Healthcare's Tivicay PD (dolutegravir) receives FDA approval for human immunodeficiency virus type 1 infection in pediatric patients weighing at least 2 kg
Small molecule, infectious disease, HIV-1, antiretroviral, integrase strand transfer inhibitor, paediatric patients - Read more
THE GOOD
Business Development & Partnerships
ProFound Therapeutics, Gates Foundation partner on preeclampsia target discovery, $35M deal with $20M upfront
Research collaboration, women's health, AI/ML, drug discovery, milestone payments, proteomics - Read more
Osivax licenses GC FLU from GC Biopharma to develop combination influenza vaccine with OVX836
Licensing deal, infectious disease, vaccine, royalties, co-development - Read more
Noetik, GSK hit first milestone in five-year AI oncology collaboration, $50M upfront
Licensing deal, oncology, AI/ML, drug discovery, milestone payments - Read more
PRESENTED BY ONYX
Meet the founders, pharma leaders and investors shaping cell & gene therapy.
Cell and Gene Live is a one-day, investor & CEO summit dedicated exclusively to Cell and Gene therapy - the science, the manufacturing, and the investment driving advanced medicines forward. All happening on November 15, 2026.
(Hosted by Onyx at The Shard in London as part of London Life Sciences Week)
Speakers confirmed include:
• Steve Bates, OBE (Chair of the UK's Department of Life Sciences)
• Dr. Erik Wiklund (CEO of Circio)
• Edwin Stone (CEO of Cellular Origins)
+ many more!
Get your tickets here - for TLDR Biotech readers, use code ANIS20 at check-out for 20% off.
✅ More Good News ✅
THE GOOD
Clinical Trials
AstraZeneca, Amgen's Tezspire (tezepelumab) hits Ph3 endpoints in eosinophilic esophagitis, targeting TSLP pathway
Antibody, autoimmune, monoclonal antibody, eosinophilic esophagitis, TSLP, Tezspire - Read more
TRexBio's TRB-061 (TRB-061) shows positive Ph1 results as TNFR2 agonist for moderate-to-severe atopic dermatitis
Antibody, autoimmune, TNFR2 agonist, atopic dermatitis, regulatory T cells - Read more
CSPC Pharmaceutical Group's (SYS6010) meets primary endpoint in Ph3 trial for epidermal growth factor receptor-mutated non-small cell lung cancer
Antibody-drug conjugate, cancer, non-small cell lung cancer, EGFR, TKI-resistant - Read more
THE GOOD
Earnings & Finances
Mesoblast reports US$120M revenue with US$104M gross profit in FY2026 financial results
Cell therapy, autoimmune, financial, revenue impact - Read more
Arctic Bioscience reports 35.2% revenue growth in H1 2026, advances HRO350 HeROPA trial publications
Nutraceutical, dermatology, revenue impact, financial - Read more
THE GOOD
Fundraises
CEPI commits up to $16.5M to advance Minapharm's Bundibugyo Ebola vaccine into clinical trials
Infectious disease, vaccine, viral vector, preclinical, modified vaccinia Ankara - Read more
Jazz Pharmaceuticals prices upsized $1.1B exchangeable senior notes offering due 2032, general corporate purposes
Specialty pharma, neurology, oncology, small molecule - Read more
Faro AI raises $37.3M Series B, scaling agentic AI across clinical development workflows
Agentic AI, clinical development, software platform, AI-driven - Read more
THE GOOD
Investments
Artis BioSolutions opens Spanish facility, expanding synthetic DNA and mRNA production capabilities for genetic medicines.
mRNA, genetic medicines, operational, manufacturing - Read more
Biosidus expands bioreactor capacity, boosting global supply of agalsidase beta for Fabry disease
Biosimilar enzyme replacement therapy, rare disease, operational, major transaction - Read more
THE GOOD
Politics & Policy
Trump to unveil MFN drug pricing deals with mid-sized biopharma companies, offering tariff relief incentives
Drug pricing, biopharma, regulatory, financial - Read more
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❌ The Bad News ❌
THE BAD
Company Shutdown
Vitruvias Therapeutics recalls 3,655 superpotent thyroid tablets, ceases operations, transfers products to H2-Pharma
Small molecule, endocrine, recall, operational - Read more
You’re all caught up on the latest Pharma & Biotech News!
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