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TROP2 ADC momentum heading into ASCO and beyond
Multiple streams of late-stage data and regulatory movement are reinforcing the commercial and clinical pull of TROP2-directed ADC strategies. An ASCO-abstract snapshot described sacituzumab...
Clinical development in rare disease and advanced genome editing
Penn and CHOP investigators reported ongoing meaningful clinical benefit from a base-editing CRISPR intervention delivered via expanded access in an infant with CPS1 deficiency, emphasizing that...
Infectious disease diagnostics and outbreak response scaling
WHO and CDC stepped up Bundibugyo Ebola outbreak diagnostics as authorities raised the threat level amid concern about broader spread in the Democratic Republic of Congo. CDC’s incident manager...
Pediatric sepsis and antibiotic dosing precision
Two pediatric sepsis-focused studies highlighted how mortality risk and dosing strategy are being refined with clinical data and interpretable modeling. A Scientific Reports analysis found sepsis...
Oncology biology: lineage plasticity and drug resistance
Pancreatic cancer research linked the zinc finger protein ZNF274 to lineage switching and resistance to CDK7-targeting therapy. The study described how ZNF274 modulates cancer cell behavior...
Metabolic vulnerabilities in cancer
Researchers reported a new cancer vulnerability tied to cholesterol transport enzymes, showing that disrupting PI5P4K-linked cholesterol trafficking can cause a cholesterol “traffic jam” that...
Spending and capital: biotech financing and IPO pipelines
Parabilis filed for an initial public offering shortly after signing an up-to-$2.3 billion strategic research collaboration with Regeneron. The company’s Helicon peptide platform targets...
Regulatory and policy pressure on supply chains and market access
Hospitals sued CVS Health over alleged manipulation of 340B program savings through spread pricing, claiming diverted savings of roughly $250 million across 2020 to 2025. The plaintiffs include...
US regulatory approval
FDA has cleared Gilead’s hepatitis D drug Hepcludex (bulevirtide) after the agency previously rejected the therapy over manufacturing and distribution concerns. The approval comes roughly four...
Oncology approvals and label expansion
FDA approved datopotamab deruxtecan (Datroway; Dato-DXd) as a first-line option for a defined subset of triple-negative breast cancer, extending the use of TROP2-directed antibody-drug conjugates...
EU regulator momentum for oncology
The EMA’s Committee for Medicinal Products for Human Use recommended Boehringer Ingelheim’s new lung drug Jascayd (nerandomilast) as part of a post-patent-cliff strategy as generic Ofev...
Phase 3 oncology readout before ASCO
Ahead of ASCO 2026, Merck and Kelun Biotech’s sacituzumab tirumotecan (sac-TMT) plus Keytruda delivered a statistically significant progression-free survival improvement in first-line,...
Finance and capital formation in biotech
Parabilis filed for an IPO a day after signing an up-to-$2.3 billion-plus strategic research collaboration with Regeneron. The Helicon platform company is seeking market funding while advancing...
Biotech licensing and clinical development funding
Oorja Bio secured $30 million in a Series A financing led by founding investor Westlake Biopartners to pursue an in-licensing approach targeting idiopathic pulmonary fibrosis and other fibrotic...
Regulatory policy and supply-chain controls
FDA issued a warning letter to a Chinese supplier, Harbin Jixianglong Biotech, after inspectors found alleged compliance failures tied to the agency’s GLP-1 import restrictions. FDA said the...
Clinical trial results in rare genetic disease
University of Pennsylvania investigators reported meaningful clinical benefits from an mRNA-based CRISPR base-editing treatment in a single patient case, involving “Baby KJ” with CPS1 deficiency....
AI and lab automation for biotech operations
Cenevo launched “Mosaic AI Inventory Search,” adding natural-language querying to Mosaic’s connected lab platform. The capability lets scientists search inventory in plain language while...
Diagnostics market expansion in Europe
Seegene received CE IVDR marking for its Allplex MDRO Assay, a multiplex real-time PCR kit designed to detect multidrug-resistant organisms and associated resistance genes linked to...
Regulatory approvals in oncology
The FDA approved datopotamab deruxtecan (Datroway/Dato-DXd) for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. The...
Phase 3 ADC readouts in lung cancer
A phase 3 study in China gave sacituzumab tirumotecan (sac-TMT) a randomized edge over Keytruda (pembrolizumab) in treatment-naïve, PD-L1–positive non-small cell lung cancer. In the...