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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The FDA officially rescinded its recent final rule governing laboratory-developed tests (LDTs), restoring the regulatory framework to prior standards that did not explicitly grant FDA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...
FDA Approves Stealth’s Barth Syndrome Therapy – First Mitochondria-Targeted Drug
The U.S. Food and Drug Administration has granted long-awaited approval to Stealth Therapeutics' Barth syndrome treatment, marking the first mitochondria-targeted therapy on the market. Barth...
Merck Gains FDA Nod for Subcutaneous Keytruda – Boosting Top-Selling Cancer Drug’s Lifespan
Merck secured FDA approval for a subcutaneous formulation of its blockbuster cancer drug Keytruda, enabling quicker administration and potentially preserving its market share against rising...
CHMP Recommends and FDA Approves Subcutaneous Keytruda Formulation
Europe’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion favoring the approval of subcutaneous Keytruda, complementing recent FDA authorization. Other treatments...
GenFleet Therapeutics Doubles in Hong Kong IPO – Biotech Market Resurgence Evident
GenFleet Therapeutics (Shanghai) Inc. made a strong Hong Kong Stock Exchange debut, with shares surging over 100% above the listing price amid renewed investor enthusiasm in biotech IPOs. The...
Dualitas Raises $65M Series A to Advance Bispecific Antibody Therapies for Autoimmune Disease
Immunology startup Dualitas Therapeutics secured $65 million to accelerate development of bispecific antibodies that simultaneously target two receptors on the same immune cell, offering superior...
Cancer Drug Pipeline Updates: Regeneron's Lynozyfic Shows 100% Response in Smoldering Multiple Myeloma
Regeneron released encouraging early data showing 100% response rates of Lynozyfic, a T-cell engager, in smoldering multiple myeloma—a precancerous state with high risk of progression. These...
Biotech Startups Spotlighted in 2025 Endpoints 11 Highlight Innovation Frontiers
The 2025 Endpoints 11 list recognized transformative private biotech companies driving groundbreaking therapies and technologies. Startups like Chai Discovery focus on AI-driven drug design, Umoja...
Advances in AI-Driven Protein Design Receive NSF Funding at UC Davis
The University of California, Davis was awarded substantial funding from the National Science Foundation to support innovative projects integrating artificial intelligence with protein...
FDA Rescinds Rule on Laboratory-Developed Tests, Reverting Regulatory Framework
The FDA has officially rescinded the 2025 final rule on laboratory-developed tests (LDTs), restoring previous regulatory oversight that does not explicitly extend FDA authority over LDTs. This...
FDA Approves Stealth's Barth Syndrome Therapy – Mitochondria-Targeted Drug Breakthrough
The FDA has granted approval for Stealth Therapeutics' therapy targeting Barth syndrome, marking the first authorized mitochondria-targeted treatment. Barth syndrome is a rare genetic disorder...
CHMP Endorses and FDA Approves Subcutaneous Keytruda to Extend Market Reach
Both the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and the FDA have recently recommended and approved a new subcutaneous (subQ) formulation of Merck's...
Genfleet Doubles in Hong Kong IPO – Promises Accelerated Biopharma Growth
Genfleet Therapeutics (Shanghai) Inc. made a successful return to the Hong Kong Stock Exchange with its IPO, raising $234 million. Shares surged 106% above the listing price on debut, reflecting...