Latest Biotech News

Viridian Therapeutics reported top-line success from its Phase 3 Reveal-2 program for elegrobart in chronic thyroid eye disease, positioning the company for a U.S. BLA filing in the first quarter...

Cytokinetics scored a Phase 3 win for aficamten (brand name Myqorzo) in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), meeting twin primary endpoints in the pivotal Acacia-HCM...

South Korea’s Ministry of Food and Drug Safety (MFDS) approved Curocell’s Rimqarto (anbalcabtagene-autoleucel; anbal-cel) as the first homegrown CAR T therapy for patients with advanced diffuse...

The FDA began piloting real-time clinical trials (RTCTs) to accelerate early-phase decision-making by having sponsors report endpoint data to the agency as results emerge. The agency described...

Veracyte raised full-year revenue guidance after strong Q1 results, driven by continued volume growth for its Decipher prostate prognostic test and Afirma thyroid cancer classifier. The company...

Intercept Pharmaceuticals’ next-generation FXR agonist INT-787 showed no clear evidence of potential in patients with severe alcohol-associated hepatitis, adding another setback for the company’s...

UK-led OpenBind released its inaugural AI-ready dataset along with a predictive AI model aimed at improving structure-based drug discovery. The initiative is positioned as a benchmark resource,...

Latus Bio closed a $97 million Series A financing to support a pipeline based on AAV capsid variants. The company expects the cash to fund operations through clinical milestones including initial...

UCB agreed to acquire Candid Therapeutics for up to $2.2 billion to expand its footprint in T-cell engager (TCE) antibodies for immunology, adding Candid’s bispecific and trispecific...

Tempus AI reported a 36% year-over-year increase in Q1 revenue to $348.1 million and raised its full-year revenue guidance, citing accelerating demand for its AI-driven diagnostic...

Veracyte reported Q1 revenue of $139.1 million, up 21% year over year, and raised full-year revenue guidance after Decipher prostate and Afirma thyroid product volumes grew faster than...

Cytokinetics said its aficamten (Myqorzo) met both Phase 3 co-primary endpoints in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) in the pivotal ACACIA program. According to the...

Viridian Therapeutics reported that its Phase 3 trial Reveal-2 met both primary endpoints for elegrobart in chronic thyroid eye disease (TED), lifting the stock as the company moves toward...

Windward Bio secured a $165 million financing to advance a long-acting anti-TSLP antibody into Phase 3 development for asthma. The Swiss biotech said the capital supports late-stage progress for a...

The FDA said it is piloting real-time clinical trials (RTCTs), a model in which sponsors report endpoint data as it is generated to speed assessment of safety signals and early efficacy. In...

South Korea’s Ministry of Food and Drug Safety (MFDS) approved Curocell Inc.’s Rimqarto (anbalcabtagene-autoleucel; anbal-cel) for advanced diffuse large B-cell lymphoma, marking the first...

Sonire Therapeutics started a U.S.-based Sunrise II study of Suizenji, its ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors. The company...

Passage Bio said it is launching a strategic review and reducing headcount by about 75% after the FDA did not support a single-arm registrational trial design for its lead program in...

The FDA moved to speed early drug development by piloting real-time clinical trials (RTCTs), where sponsors report safety and endpoint signals to the agency as data are generated. The agency...

Madrigal Pharmaceuticals expanded its metabolic dysfunction-associated steatohepatitis (MASH) combination strategy by licensing an Arrowhead Pharmaceuticals small-interfering RNA therapy tied to a...