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FDA Approves Subcutaneous Keytruda and Berahyaluronidase Combination
The FDA has approved a subcutaneous formulation of Merck's Keytruda (pembrolizumab) in combination with berahyaluronidase alfa-pmph, expanding administration options for this leading...
GenFleet Therapeutics' IPO Doubles on Hong Kong Debut
GenFleet Therapeutics (Shanghai) completed a successful initial public offering on the Hong Kong Stock Exchange, raising approximately $234 million. The company's shares surged over 100% on the...
Dualitas Raises $65 Million for Bispecific Antibody Autoimmune Therapies
Dualitas Therapeutics secured $65 million in Series A funding to advance its bispecific antibody platform targeting two immune cell surface proteins simultaneously. This proximity biology approach...
Cellares Expands Automated QC Platform for Commercial Cell Therapy Scale-Up
Cellares announced strategic partnerships with technology providers including Tecan, Advanced Instruments, and Cytek Biosciences to enhance its Cell Q automated quality control platform for cell...
QL Biopharm’s Monthly GLP-1 Agonist Zovaglutide Hits Phase II Obesity Trial Endpoints
Chinese biotech QL Biopharm reported that its once-monthly GLP-1 receptor agonist, zovaglutide (ZT-002), met primary and secondary endpoints in a randomized, placebo-controlled phase II obesity...
House Committee Advances Bill to Restore Rare Pediatric Disease Priority Review Vouchers
The U.S. House Energy and Commerce Committee voted unanimously (47-0) to advance the Give Kids a Chance Act of 2025, aiming to reinstate the Rare Pediatric Disease Priority Review Voucher (RPD...
Roche Completes $3.5 Billion Acquisition of 89bio for Fatty Liver Disease Treatment
Roche announced a definitive agreement to acquire 89bio for up to $3.5 billion, including upfront cash of $2.4 billion and milestone payments. 89bio's lead asset, pegozafermin, is an FGF21 analog...
Regeneron’s Lynozyfic T Cell Engager Shows 100% Response in Smoldering Multiple Myeloma
Regeneron reported promising early clinical data demonstrating a 100% response rate for Lynozyfic, its T cell engager therapy, in a study of small smoldering multiple myeloma patients. This...
Advances in AI-Driven Protein Design Secured $43.6 Million NIH Grant for Clinical Research
The University of Arizona and University of New Mexico together secured a combined $43.6 million NIH grant to support a collaborative initiative aimed at advancing translational clinical research...
FDA Approves Subcutaneous Keytruda and Other Cancer Therapies
The U.S. FDA has approved a subcutaneous formulation of Merck's Keytruda, aiming to extend the market life of the world's top-selling cancer drug by easing administration. This new approval comes...
Stealth Therapeutics Secures FDA Approval for Barth Syndrome Treatment
Stealth Therapeutics attained a long-awaited FDA approval for its mitochondrial-targeted therapy designed to treat Barth syndrome, marking a milestone for this rare genetic disorder. Barth...
Dualitas Therapeutics Raises $65M for Bispecific Antibody Development
Dualitas Therapeutics announced a $65 million Series A financing to advance its bispecific antibody platform targeting immune and inflammatory diseases. The company’s technology leverages...
Genomic Insights into Disease and Population: Dengue Mosquito and Plasma Metabolome Studies
Two pivotal studies deliver novel genomic insights impacting public health and precision medicine. First, sequencing of over 1,200 Aedes aegypti mosquitoes reveals adaptations underlying...
UCSF Deploys CRISPR Activation to Treat SCN2A-Related Neurodevelopmental Disorders
Researchers at UCSF demonstrated that CRISPR activation of the functional SCN2A gene copy in mouse models restores synaptic maturation and mitigates seizure susceptibility, representing a...
Roche to Acquire 89bio for $3.5 Billion, Targeting NASH Market Expansion
Roche announced a definitive agreement to acquire biotech firm 89bio for up to $3.5 billion, acquiring pegozafermin, a promising FGF21 analogue in Phase III trials for moderate to severe metabolic...
AI and Automation Transform Cell Therapy Quality Control at Cellares
Cellares has launched the Cell Q platform, an automated quality control solution tailored for commercial-scale cell therapy manufacturing. Developed through strategic partnerships with Tecan,...
Endpoints 11 Recognizes Top Biotech Startups Driving Innovation in 2025
The 2025 Endpoints 11 list spotlights eleven private biotech companies demonstrating cutting-edge innovation across diverse therapeutic areas, including AI-driven drug design, in vivo CAR-T...
CDC Advisory Panel Revises COVID-19 Vaccination Recommendations Amid Controversy
The CDC’s Advisory Committee on Immunization Practices (ACIP), restructured by Health and Human Services Secretary Robert F. Kennedy Jr., postponed votes on hepatitis B birth dose and voted to...
Emerging Cancer Therapies: ADCs Advance in Precision Oncology
Antibody-drug conjugates (ADCs) continue to gain traction as a precision oncology modality, delivering cytotoxic agents directly to cancer cells and reducing systemic toxicities. Recent clinical...
FDA Approves Stealth’s First Mitochondria-Targeted Barth Syndrome Therapy
The FDA has granted approval to Stealth’s Barth syndrome therapy, marking the first mitochondria-targeted treatment option for this rare genetic disorder. Barth syndrome primarily affects cardiac...