Latest Biotech News

The FDA has begun piloting real-time clinical trials (RTCTs) designed to speed early-phase decision-making by allowing sponsors to report safety and endpoint signals as data are generated. The...

UCB agreed to buy Candid Therapeutics for $2 billion up front, adding two clinical-stage bispecific T-cell engager programs to its autoimmune pipeline, including the lead BCMA/CD3 asset cizutamig...

Viridian Therapeutics’ elegrobart scored another Phase 3 win in chronic thyroid eye disease, rebuilding investor confidence after earlier results disappointed. Analysts framed the new data as more...

Pfizer ended the remaining clinical development tied to its $2.3 billion Trillium Therapeutics acquisition, scrapping the second and final clinical-stage candidate linked to the CD47 blocker and...

Beone Medicines secured an exclusive worldwide option to develop Huahui Health’s trispecific antibody HH-160 in a deal potentially worth more than $2 billion. The arrangement gives Beone global...

South Korea’s MFDS approved Curocell’s Rimqarto (anbal-cel), positioning it as the first homegrown CAR T-cell therapy for advanced diffuse large B-cell lymphoma. The approval marks a manufacturing...

Applied BioCode received expanded FDA 510(k) clearance for its BioCode Respiratory Pathogen Panel, adding automated extraction using Thermo Fisher Scientific’s KingFisher Flex platform. The...

Cytospire Therapeutics raised £61 million (about $83 million) in a Series A to advance its pan gamma-delta T-cell engager platform toward clinical proof-of-concept. The company’s lead program, CYT...

Passage Bio disclosed a strategic review alongside layoffs after FDA feedback shifted the design requirements for its lead gene therapy in frontotemporal dementia with granulin mutations....

Latus Bio closed a $97 million Series A to fund its AAV capsid-variant platform, with initial clinical work expected to start across Huntington’s disease (LTS-201) and late-infantile neuronal...

UCB is accelerating its immunology expansion by agreeing to buy Candid Therapeutics in a deal valued at $2 billion up front, with up to $200 million in additional milestone payments. The...

The FDA launched pilot efforts for real-time clinical trials (RTCTs) designed to compress early-phase timelines by sharing endpoint and safety signals as they are generated. The agency said it...

Vertex is discontinuing its mRNA-based cystic fibrosis development program after unresolved tolerability issues, following earlier trial pausing tied to patient tolerability. The Boston-based...

Celcuity’s experimental PI3K/mTOR inhibitor gedatolisib cleared a Phase 3 primary endpoint in PIK3CA-mutant, HER-positive/HER2-negative, advanced breast cancer data, strengthening its case for FDA...

Cytokinetics’ Myqorzo secured twin efficacy targets in a Phase 3 trial of non-obstructive hypertrophic cardiomyopathy (ACACIA), providing a counterpoint to Bristol Myers Squibb’s Camzyos efforts...

Biodesix reported a 42% year-over-year jump in first-quarter 2026 revenue and raised its full-year guidance after diagnostic test volumes and average revenue per test increased. For the three...

Sophia Genetics reported first-quarter growth driven by expanded use of its Sophia DDM platform, recording a 22% revenue increase. The company also highlighted platform activity with a record...

Applied BioCode expanded the usability of its BioCode Respiratory Pathogen Panel (RPP) after receiving expanded FDA 510(k) clearance to pair the assay with Thermo Fisher Scientific’s KingFisher...

Passage Bio disclosed a strategic review and planned workforce reduction after a Type C meeting with the FDA pushed the company away from a single-arm registrational design for PBFT02 in...

Revvity said it plans to divest its China immunodiagnostics business after entering a letter of intent with an undisclosed buyer, with a definitive agreement expected in Q2 2026. Revvity expects...