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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The FDA has officially rescinded the 2025 final rule on laboratory-developed tests (LDTs), restoring previous regulatory oversight that does not explicitly extend FDA authority over LDTs.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...
Dualitas Advances Bispecific Antibodies with $65M Series A to Tackle Autoimmune Diseases
Dualitas Therapeutics secured $65 million in Series A funding to drive the development of bispecific antibodies that simultaneously engage two immune cell targets. This proximity biology-based...
Endpoints 11: Highlighting AI-Driven and Cell Therapy Startups Defining 2025 Biotech
The 2025 Endpoints 11 list spotlights 11 private biotech companies driving innovation across AI-powered drug design, in vivo CAR-T therapies, and autoimmune disease treatments. Notable recipients...
Roche to Acquire 89bio for $3.5B, Eyeing MASH and Metabolic Disease Leadership
Roche announced a definitive agreement to acquire 89bio for up to $3.5 billion, centered on 89bio’s lead candidate pegozafermin, a fibroblast growth factor 21 (FGF21) analogue in Phase III for...
Cellares and Partners to Enhance Cell Q Platform for High-Throughput Cell Therapy Quality Control
Cellares has forged partnerships with leading technology providers including Tecan, Advanced Instruments, Cytek Biosciences, and Slingshot Biosciences to expand and automate its Cell Q platform....
Regeneron’s Lynozyfic Shows 100% Response in Early Study for Smoldering Multiple Myeloma
Regeneron Incorporated reported compelling early clinical data demonstrating 100% response rate in a small study of its T cell engager drug Lynozyfic in patients with smoldering multiple myeloma,...
New Subcutaneous GLP-1 Diabetes Treatment Recommended by CHMP for EU Approval
The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended EU approval of Bayer’s Lynkuet (elinzanetant), a dual neurokinin-1 and neurokinin-3 receptor antagonist for treating...
U.S. CDC Advisory Panel Delays Vote on Hepatitis B Birth Dose Amid Safety and Necessity Concerns
The Advisory Committee on Immunization Practices (ACIP), restructured by Health and Human Services Secretary Robert F. Kennedy Jr., postponed the vote on whether to delay the hepatitis B vaccine...
FDA Clears Stealth's Barth Syndrome Therapy: First Mitochondria-Targeted Option
The FDA has granted long-awaited approval to Stealth Therapeutics' novel treatment for Barth syndrome, marking the first mitochondria-targeted therapy available for this rare genetic disorder....