Latest Biotech News

UCB agreed to acquire Candid Therapeutics for up to $2.2 billion, a deal designed to expand UCB’s portfolio of T-cell engager (TCE) antibodies in autoimmune and inflammatory disease. The...

The FDA is moving to speed up early drug development by piloting real-time clinical trials (RTCTs), where sponsors report endpoint and signal data to the agency as it is generated. The agency says...

Cytokinetics said its Phase 3 ACACIA trial hit twin efficacy goals in symptomatic, non-obstructive hypertrophic cardiomyopathy, with Myqorzo (aficamten) improving both patient-reported symptom...

Viridian Therapeutics posted positive Phase 3 top-line results for elegrobart (VRDN-003) in chronic thyroid eye disease, clearing the way for planned regulatory filings. The company said the trial...

Avalo Therapeutics’ Phase 2 trial in hidradenitis suppurativa (HS) hit its primary endpoint, but the placebo-adjusted result missed the company’s internal bar, a dynamic that still moved the...

Tempus reported a 36% year-over-year increase in Q1 revenue to $348.1 million and raised full-year guidance, citing acceleration in oncology testing and continued demand for its AI-enabled...

Labcorp and Fox Chase Cancer Center are collaborating on a clinical trial using the Plasma Detect test for molecular monitoring in non-small cell lung cancer (NSCLC). The study will test patients...

Madrigal Pharmaceuticals extended its MASH deal strategy by securing a global licensing arrangement for an Arrowhead Pharmaceuticals asset that targets a genetic driver of metabolic...

Latus Bio closed a $97 million Series A to advance an AAV-capsid variant platform for gene therapies, with initial clinical data expected from two lead programs: LTS-201 for Huntington’s disease...

South Korea’s MFDS approved Curocell’s Rimqarto (anbal-cel; anbalcabtagene-autoleucel) as the first homegrown CAR T-cell therapy for advanced diffuse large B-cell lymphoma. The authorization marks...

UCB agreed to acquire Candid Therapeutics for up to $2.2 billion, expanding its presence in T-cell engager (TCE) antibodies for immunology indications. The deal adds Candid’s bispecific and...

A conference report from Rome highlighted how FDA decisions are shaping sentiment for the gene therapy and cell therapy sector, even as industry leaders look for opportunities in Europe. The...

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...