Latest Biotech News

The U.S. Department of Health and Human Services (HHS) has rolled out a department-wide plan—Operation Trailblazer—to speed up early-stage prescription drug development amid intensifying...

Regenxbio said the FDA will reconsider its mucopolysaccharidosis type II (Hunter syndrome) gene therapy (Navsunli / RGX-121) after the agency rejected the filing earlier this year. Regenxbio said...

Sangamo Therapeutics has filed for Chapter 11 bankruptcy and agreed to sell multiple platforms and programs via stalking-horse bids. Eli Lilly will acquire Sangamo’s capsid delivery, zinc finger...

AbbVie has agreed to acquire Apogee Therapeutics for $10.9 billion in cash, valuing the clinical-stage biotech at $135.11 per share. The deal centers on zumilokibart (APG777), a half-life extended...

Natera’s Signatera minimal residual disease (MRD) test has been included in updated NCCN guidelines for muscle-invasive bladder cancer. The National Comprehensive Cancer Network recommends...

Cadence has raised $100 million in Series C funding to scale its AI-powered chronic care platform that monitors patients at home and adjusts medications in real time. The startup is valued at...

Eli Lilly has signed a research and collaboration agreement with BioArctic to combine Lilly’s undisclosed drug candidate with BioArctic’s BrainTransporter technology, aiming to address the...

Researchers unveiled an enzyme-independent continuous glucose monitoring approach using an acoustically readable microneedle patch (ARMPatch). The device is designed to convert ultrasound...

Definium Therapeutics reported top-line results from a Phase 3 trial of DT-120 (lysergide, LSD) in major depressive disorder, saying the single-dose therapy significantly improved depression...

China’s National Medical Products Administration (NMPA) approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid...

AbbVie agreed to acquire Apogee Therapeutics for $10.9 billion in cash, betting on zumilokibart (APG777), a long-acting monoclonal antibody targeting IL-13. The deal values Apogee at $135.11 per...

Pfizer’s first ADC flowing from its 2023 Seagen acquisition, sigvotatug vedotin (SV), failed to reach statistical significance on overall survival in a Phase 3 non-small-cell lung cancer (NSCLC)...

The U.S. Department of Health and Human Services launched Operation Trailblazer, a department-wide strategy aimed at making early-stage prescription drug development faster. The blueprint focuses...

The FDA said it would reconsider Regenxbio’s Hunter syndrome gene therapy (RGX-121) after rejecting the application earlier this year. Regenxbio said the agency acknowledged existing clinical data...

As CAR-T moves into solid tumors, regulators are also shaping how developers validate targets and efficacy. The Carsgen satri-cel approval places Claudin18.2 CAR T into a new category of...

Eli Lilly moved to withhold 340B discounts from hospitals that did not comply with new paperwork requirements, triggering backlash from hospital groups and appeals for federal oversight. Multiple...

Osanni Bio raised $190 million in a Series B to build a portfolio focused on ophthalmology and cardiology. The San Francisco biotech is pursuing a structure that creates “affiliate companies” to...

Ladder Health raised $7 million in seed funding to expand a virtual-first pediatric therapy model. The round was led by Nina Capital with participation from multiple venture and health-focused...

K2 Therapeutics acquired ex-China rights to two preclinical Antengene bispecific T-cell engager (TCE) assets through a license and option agreement. The package is valued at $980.5 million each,...

The U.S. Department of Health and Human Services unveiled a blueprint to speed and streamline early clinical development, targeting first-in-human timelines of 6–12 months shorter. The package...