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FDA Approves Subcutaneous Keytruda in Bid to Extend Market Lead
The FDA approved a new subcutaneous formulation of Merck’s blockbuster cancer drug Keytruda, aiming to maintain its competitive edge against emerging biosimilars. This approval represents a...
FDA Grants Approval for Stealth’s Barth Syndrome Mitochondrial Therapy
The FDA granted long-anticipated approval to Stealth Therapeutics’ Barth syndrome therapy, marking the first mitochondria-targeted treatment authorized for this rare genetic disorder. Barth...
Dualitas Secures $65M Series A to Develop Bispecific Immunotherapy Antibodies
Immunology startup Dualitas announced a $65 million Series A funding round to advance its bispecific antibody platform targeting two receptors on the same immune cell. Led by investors including...
Cellares Expands Cell Q Platform with Strategic Partnerships for Commercial-Scale QC Automation
Cell therapy CDMO Cellares revealed multiple technology partnerships to enhance its Cell Q platform, delivering fully automated quality control testing at commercial manufacturing scale. The...
New AI-Based Methods Advance Lithium-Ion Battery Health and Lifespan Prediction
Researchers introduced pioneering artificial intelligence techniques to improve the estimation of lithium-ion battery state of health (SOH) and remaining useful life (RUL). Employing deep learning...
Groundbreaking CAR T-Cell Access Challenges and Manufacturing Automation Progress
Expanding CAR T-cell therapies remains a critical objective amid challenges managing cytokine release syndrome (CRS) and neurotoxicity (ICANS). Industry leaders emphasize strategies to broaden...
Advances in Neonatal Medicine Reveal Caffeine’s Impact on Premature Infant Neurodevelopment
Recent studies published in Pediatric Research and related journals demonstrate that cumulative caffeine exposure in premature infants correlates with neurodevelopmental outcomes. These findings...
AI-Powered Protein Design and Translational Research Boosted by Major NSF Funding
The University of California, Davis, has secured significant National Science Foundation grants to propel AI-driven protein engineering and translational clinical research. Additionally, the...
Regulatory Shifts: FDA Rescinds Rule on Laboratory-Developed Tests
The FDA withdrew its final rule on laboratory-developed tests (LDTs), reverting to prior regulatory frameworks that limit agency oversight of these in vitro diagnostics. This decision impacts...
Biopharma Financing Trends Show Significant Investment Momentum Through 2025
Year-to-date data indicate robust fundraising activity in the biopharmaceutical sector, including public offerings, private placements, and financing rounds. This financial momentum supports...
FDA Approves Stealth's Barth Syndrome Therapy – First Mitochondria-Targeted Drug
The U.S. Food and Drug Administration (FDA) granted approval to Stealth Therapeutics' drug for Barth syndrome, marking the first mitochondria-targeted therapeutic approved for this rare genetic...
Merck Secures FDA Nod for Subcutaneous Keytruda to Extend Blockbuster's Lifecycle
Merck has received FDA approval for a subcutaneous formulation of its leading cancer immunotherapy, Keytruda. This new administration method offers improved patient convenience over intravenous...
CHMP Recommends and FDA Approves Subcutaneous Keytruda Amid Immuno-Oncology Advances
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of subcutaneous Keytruda, complementing recent FDA approval. This progress signifies...
Dualitas Raises $65M to Advance Bispecific Antibody Therapies in Autoimmune Disease
Dualitas Therapeutics secured $65 million in Series A funding to accelerate development of bispecific antibodies designed to engage two immune targets simultaneously. This approach, leveraging...
Advances in AI-Driven Cell Therapy Quality Control with Cellares’ Cell Q Platform
Cellares has unveiled strategic technology partnerships to enhance its Cell Q platform, an automated quality control system tailored for commercial-scale cell therapy manufacturing. This modular...
QL Biopharm's Once-Monthly GLP-1 Agonist Hits Phase II Obesity Trial Endpoints
Beijing-based QL Biopharmaceutical announced that its once-monthly GLP-1 receptor agonist, zovaglutide (ZT-002), achieved primary and secondary efficacy endpoints in a randomized phase II trial...
Regeneron's Lynozyfic Shows 100% Response in Early Smoldering Multiple Myeloma Study
Regeneron Pharmaceuticals presented early clinical data on Lynozyfic, a T cell engager demonstrating a 100% response rate in patients with smoldering multiple myeloma. The results mark a promising...
Genfleet’s IPO Doubles Valuation on Hong Kong Exchange Debut
Genfleet Therapeutics (Shanghai) Inc. successfully completed its IPO on the Hong Kong Stock Exchange, raising $234 million. Shares surged approximately 106% above the listing price on the first...
University of Arizona and New Mexico Receive $43.6M NIH Grant for Translational Research
The NIH awarded a seven-year grant totaling $43.6 million to the University of Arizona and University of New Mexico for a collaborative translational clinical research initiative. The project aims...
FDA Rescinds Controversial Rule on Laboratory-Developed Tests, Returning Regulatory Authority
The FDA officially rescinded its recent final rule governing laboratory-developed tests (LDTs), restoring the regulatory framework to prior standards that did not explicitly grant FDA authority...