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FDA accelerated approval for Replimune melanoma therapy
The FDA granted accelerated approval to Replimune’s oncolytic viral therapy Tudriqev (formerly RP1) for advanced melanoma, ending a two-rejection regulatory saga that included advisory committee...
Takeda wins FDA nod for first-in-class narcolepsy type 1 therapy
The FDA approved Takeda’s oral orexin receptor 2 agonist Orzeyful (oveporexton/TAK-861), marking the first approved therapy designed to address the underlying biology of narcolepsy type 1 in...
Moderna secures FDA approval for first mRNA seasonal flu vaccine
The FDA approved Moderna’s mRNA influenza vaccine mFLUSIVA (mRNA-1010), making it the first mRNA-based seasonal flu shot cleared in the U.S. Regulators previously declined to review the submission...
Spatial genomics patent litigation moves forward in federal court
Spatial Genomics and Caltech filed a lawsuit in the U.S. District Court for the District of Delaware accusing 10x Genomics’ Xenium spatial biology platform of infringing five patents covering...
New rapid point-of-care respiratory multiplex test submission
Co-Diagnostics filed a 510(k) premarket notification with the FDA for its point-of-care upper respiratory infection test, Co-Dx PCR Flu A/B, and RSV. The assay is designed to differentiate...
Big biotech fundraising milestone: UK biotech VC hits 5-year high
UK biotech venture capital surged to a five-year high in Q2 2026, reaching £2.05 billion ($2.76 billion) according to figures from the BioIndustry Association. The report cited Isomorphic Labs’...
Protein degraders: Dana-Farber platform discovers metabolically activated molecular glue
Dana-Farber Cancer Institute researchers unveiled a platform for systematically discovering molecular glue degraders, aiming to broaden the druggable space beyond conventional inhibitor targets....
Novel platform speeds bacterial gene mapping for biotech design
Oak Ridge National Laboratory researchers developed a platform that rapidly identifies genetic triggers enabling engineered bacteria to act as more efficient factories for chemicals and materials....
AI-designed phages enter clinic-adjacent conversation as biosafety risks emerge
Researchers at Stanford University used generative AI to design complete bacteriophage genomes and then synthesized and tested the resulting viruses against bacteria, including...
Takeda-backed CSF1R inhibitor IP enters protection cycle
Neurodawn Pharmaceutical disclosed patent protection for a new set of pyridine derivatives targeting CSF1R (CD115), a receptor expressed on myeloid cells. The company described potential uses...
Regulatory approvals: oncology and rare disease
The FDA granted accelerated approval to Replimune’s oncolytic virus therapy Tudriqev (formerly RP1, to be used with Opdivo) for advanced melanoma, following a two-time rejection saga that included...
Regulatory review looming: cancer screening test
The FDA will convene an advisory committee meeting in September to review Grail’s Galleri, a blood-based multi-cancer early detection test that failed to meet the primary endpoint in a large...
Market and clinical evidence: obesity treatment preferences
A new specialist survey from Spherix Global Insights finds Eli Lilly’s injectable GLP-1 therapy Zepbound remains the most preferred among clinicians surveyed, even as oral obesity options enter...
AI and drug discovery operations in oncology
OneOncology, a network of community oncology practices, will embed OpenEvidence’s AI chatbot and search engine into physician workflows, aiming to support decision-making and accelerate literature...
Non-opioid pain pipeline meets the public markets
Latigo Biotherapeutics priced an IPO Aug. 7, raising $345.6 million to fund development of a non-opioid pain pipeline targeting Nav1.8. The offering reflects continued appetite for mechanism-led,...
Oncology platform expansion: spatial biology demand and outlook
10x Genomics raised its 2026 revenue guidance after strong demand for its Atera spatial biology platform, which begins shipping in the second half of the year. CFO Adam Taich said booked orders...
Genomics and diagnostics: spatial patent dispute threatens platform traction
Spatial Genomics and Caltech filed a lawsuit in the District of Delaware alleging that 10x Genomics’ Xenium spatial biology platform infringes Caltech patents tied to sequential hybridization...
Clinical trials and regulatory pipeline: targeted accelerated development
FDA fast track and priority review designations in July 2026 spotlight continued acceleration for oncology drug candidates across multiple histologies. SOTIO Biotech’s CDH17-targeting ADC SOT109...
Biopharma finance: UPSIZED IPOs extend 2026’s listing momentum
Braveheart Bio priced an upsized IPO, raising $382.5 million gross, to advance its oral cardiac myosin inhibitor BHB-1893 through Phase 3 programs in hypertrophic cardiomyopathy. The company is...
Clinical and platform innovation: microbiome therapy signals in food allergy
A Phase I open-label trial at Boston Children’s Hospital reported that oral encapsulated fecal microbiome transplantation (FMT) capsules can increase peanut tolerance in adults with peanut...