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Latest Biotech News

TROP2 ADC momentum heading into ASCO and beyond

May 24, 2026

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

May 24, 2026

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

May 24, 2026

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

May 24, 2026

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

May 24, 2026

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

May 24, 2026

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

May 24, 2026

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

May 24, 2026

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

May 23, 2026

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

May 23, 2026

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

May 23, 2026

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

May 23, 2026

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

May 23, 2026

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

May 23, 2026

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

May 23, 2026

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

May 23, 2026

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

May 23, 2026

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

May 23, 2026

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

May 23, 2026

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

May 23, 2026

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...