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Late-stage efficacy signals in solid tumors
A phase 3 ENGOT-ENG-NSGO/GOG-3031/RUBY update showed durable disease control with dostarlimab plus chemotherapy in dMMR/MSI-H endometrial cancer. At a median follow-up of 55.6 months, 4-year...
Adc approval in breast cancer
The FDA approved datopotamab deruxtecan (Dato-DXd; Datroway) for unresectable or metastatic triple-negative breast cancer patients who are not candidates for PD-1/PD-L1 inhibitor therapy. The...
Gene editing clinical expansion and scientific framing
A University of Pennsylvania and Children’s Hospital of Philadelphia case study highlighted meaningful clinical benefits from an mRNA-based CRISPR base-editing approach in an infant with CPS1...
Capital markets and corporate deals
Parabilis moved to the public markets with an IPO filing a day after signing an up-to-$2.3 billion-plus Regeneron collaboration. The Helicon-based antibody-drug conjugate platform deal centers on...
Regulatory and trade policy pressure on biotech investment
US policy pressure is building around outbound capital flows into China biotech, with lawmakers urging restrictions. A GOP lawmaker asked the Trump administration to curb China biotech deals,...
FDA-aligned clinical development in rare hematology
Researchers unveiled a prognostic nomogram designed to predict early outcomes in childhood aplastic anemia for patients treated with cyclosporine monotherapy. The model targets a long-standing...
Workforce and operational changes
AbbVie began another round of layoffs tied to its Allergan footprint, issuing a WARN notice for 85 permanent job cuts at its Irvine, California site. The company framed the actions within its eye...
Biotech tools and connected lab automation
Cenevo launched an AI-enabled inventory search capability for its Mosaic connected-lab platform, designed to let scientists query labware and stored samples using natural language. The feature,...
US regulatory approval—breast cancer ADCs
The FDA cleared AstraZeneca and Daiichi Sankyo’s TROP2-directed antibody-drug conjugate Datroway for first-line treatment of triple-negative breast cancer (TNBC) when patients are not candidates...
EU regulatory decision—Boehringer’s Jascayd and others
The EMA’s Committee for Medicinal Products for Human Use recommended Boehringer Ingelheim’s nerandomilast, branded as Jascayd, as a replacement option as generic nintedanib (Ofev) approaches the...
US drug approval comeback—Hepatitis D after prior FDA rejection
The FDA approved Gilead’s hepatitis D therapy Hepcludex (bulevirtide) roughly four years after the agency rejected the drug earlier, citing manufacturing and distribution concerns. The approval...
Oncology science—cholesterol transport enzymes as cancer vulnerability
Researchers at Sanford Burnham Prebys and collaborators at the University of Illinois Chicago reported in Science Advances that phosphoinositide kinases PI5P4Ks help regulate cholesterol...
CRISPR base editing—expanded-access case sets expectations
A University of Pennsylvania and Children’s Hospital of Philadelphia report that an mRNA-based CRISPR base editing therapy delivered to infant “Baby KJ” with CPS1 deficiency produced meaningful...
Biotech finance—Parabilis IPO following Regeneron deal
Parabilis filed for an initial public offering on the heels of a strategic research collaboration with Regeneron. The partnership spans up to $2.3 billion in potential payments and covers...
EU biotech funding—new growth fund to narrow capital gap
QEt’s proposed €5 billion cross-sector growth fund is positioned to address European biotech’s funding shortfall by creating another homegrown route for growth capital. The initiative is framed...
China clinical trials policy—new IIT rules and gray market effects
China’s new rules for investigator-initiated trials (IITs) are expected to tighten oversight while legitimizing pathways for modalities beyond cell and gene therapies, according to reporting on...
ASCO pre-meeting—cost-utility and perioperative readouts
Ahead of the 2026 ASCO Annual Meeting, organizers lifted the pre-meeting embargo on May 21 and highlighted multiple trial readouts across lung, gastrointestinal, and genitourinary cancers. The...
Company actions—Vizgen layoffs during restructuring
Vizgen laid off an unspecified number of employees as part of a strategic reorganization, according to company statements and employee reports. The spatial technology company said it is investing...
Regulatory approvals and pipeline milestones (oncology focus)
The FDA has approved datopotamab deruxtecan (Datroway; Dato-DXd) as a first-line option for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for...
Regulatory decisions on liver disease (hepatitis D)
Gilead won US approval for its hepatitis D drug Hepcludex (bulevirtide) after the FDA previously rejected the therapy roughly four years earlier. The agency cited manufacturing and distribution...