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Subcutaneous Keytruda Gains FDA and CHMP Backing
Both the FDA and the European CHMP have recommended and approved subcutaneous formulations of Keytruda, streamlining administration of this widely used cancer immunotherapy. This approval,...
Dualitas Raises $65 Million for Bispecific Autoimmune Drugs
Dualitas Therapeutics secured $65 million in Series A funding to advance its bispecific antibody platform, which targets two immune cell receptors simultaneously for enhanced modulation in...
GenFleet IPO Doubles on Hong Kong Market Debut
GenFleet’s shares doubled in their first day of trading on the Hong Kong Exchange, signaling strong investor appetite for biotech equities in the region. This IPO continues the momentum of biotech...
MapLight Files IPO to Fund Schizophrenia and Alzheimer’s R&D
MapLight Therapeutics has filed for an initial public offering to support development of novel treatments targeting schizophrenia and Alzheimer's disease. The company’s pipeline focuses on...
Han et al Introduce TMolNet for Molecular Property Prediction
A new multimodal neural network, TMolNet, has been developed to improve molecular property prediction, integrating task-awareness and chemical modalities. Led by Han, Tang, and Lu, this AI-driven...
CAR T Therapy Access Hinges on Managing Toxicities
The expansion of CAR T-cell therapies faces hurdles due to toxicity management challenges such as cytokine release syndrome and neurotoxicity. Experts stress the need for improved strategies to...
AI Insights Extend Lithium-Ion Battery Lifespans
Researchers have applied artificial intelligence to estimate remaining useful life of lithium-ion batteries with greater precision. This advancement supports longer device performance and more...
University of Arizona, UNM Awarded $43.6M NIH Grant
The NIH has granted $43.6 million over seven years to the University of Arizona and University of New Mexico to enhance translational clinical research. This collaborative project aims to improve...
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...