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Beren Therapeutics Showcases Adrabetadex Data at APMRF Conference

Beren Therapeutics Showcases Adrabetadex Data at APMRF Conference

Beren Therapeutics Showcases Adrabetadex Data at APMRF Conference
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Fulcrum Therapeutics Halts Development of Sickle Cell Drug Pociredir Amid Safety Concerns

Fulcrum Therapeutics Halts Development of Sickle Cell Drug Pociredir Amid Safety Concerns

Fulcrum Therapeutics Halts Development of Sickle Cell Drug Pociredir Amid Safety Concerns
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Acting US FDA chief meets with rare disease groups to mend fences

Acting US FDA chief meets with rare disease groups to mend fences

By Chris Prentice NEW YORK, June 3 (Reuters) - Acting U.S. FDA Commissioner Kyle Diamantas is meeting with rare disease groups on Wednesday, according to groups attending and a government official, as the new chief seeks to repair relations with a sector disappointed by his predecessor.
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Decoy Therapeutics and hVIVO Collaborate to Advance Antiviral Drug Development

Decoy Therapeutics and hVIVO Collaborate to Advance Antiviral Drug Development

Decoy Therapeutics and hVIVO Collaborate to Advance Antiviral Drug Development
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Tune Therapeutics Unveils Promising Data for Hepatitis B Treatment at EASL 2026

Tune Therapeutics Unveils Promising Data for Hepatitis B Treatment at EASL 2026

Tune Therapeutics has presented positive Phase 1b/2a proof of concept data for TUNE-401, an epigenetic silencer for hepatitis B, at the European Association for the Study of Liver (EASL) Congress. The study demonstrated deep and durable antiviral activity, including direct silencing of cccDNA, a key barrier to curing chronic hepatitis B (CHB). TUNE-401, delivered intravenously, showed dose-dependent repression of HBV biomarkers and was well-tolerated in patients. The trial included single and multiple-dose cohorts, with biomarker repression observed in 100% of participants at higher dose levels. The study's findings suggest a potential pathway to a finite cure for HBV patients.
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Terremoto Biosciences Receives FDA Fast Track Designation for Breast Cancer Drug TER-2013

Terremoto Biosciences Receives FDA Fast Track Designation for Breast Cancer Drug TER-2013

Terremoto Biosciences Receives FDA Fast Track Designation for Breast Cancer Drug TER-2013
Reuters Reuters
US FDA to review AI-based tool to predict drug-related liver damage

US FDA to review AI-based tool to predict drug-related liver damage

June 3 (Reuters) - The U.S. FDA's Center for Drug Evaluation and Research said on Wednesday it has accepted a letter of intent for an artificial intelligence-based drug development tool designed to help predict drug-induced liver injury.
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Terremoto Biosciences Receives FDA Fast Track Designation for Breast Cancer Drug

Terremoto Biosciences Receives FDA Fast Track Designation for Breast Cancer Drug

Terremoto Biosciences Receives FDA Fast Track Designation for Breast Cancer Drug
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Paradigm Health Launches New Clinical Trial Solution for Observational Study

Paradigm Health Launches New Clinical Trial Solution for Observational Study

Paradigm Health Launches New Clinical Trial Solution for Observational Study
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Servier Presents Promising Phase 1 Data for Emiltatug Ledadotin in Adenoid Cystic Carcinoma

Servier Presents Promising Phase 1 Data for Emiltatug Ledadotin in Adenoid Cystic Carcinoma

Servier has announced encouraging Phase 1 clinical trial results for Emiltatug Ledadotin (Emi-Le), an investigational antibody drug conjugate (ADC) targeting B7-H4, at the ASCO 2026 Annual Meeting. The trial involved 180 patients with advanced or metastatic solid tumors, including 48 with adenoid cystic carcinoma (ACC). Emi-Le demonstrated a favorable safety profile and promising efficacy, with a 35.6% objective response rate and an 82.2% disease control rate among ACC patients. The U.S. FDA has granted Breakthrough Designation to Emi-Le for treating locally advanced, recurrent, or metastatic ACC, highlighting the critical need for targeted therapies in this patient population.
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Decoy Therapeutics Partners with hVIVO to Advance Antiviral Candidate into Clinical Trials

Decoy Therapeutics Partners with hVIVO to Advance Antiviral Candidate into Clinical Trials

Decoy Therapeutics Partners with hVIVO to Advance Antiviral Candidate into Clinical Trials
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Corcept Therapeutics Presents Promising Survival Data for Lifyorli in Ovarian Cancer Treatment

Corcept Therapeutics Presents Promising Survival Data for Lifyorli in Ovarian Cancer Treatment

Corcept Therapeutics Incorporated has presented new data at the ASCO 2026 Annual Meeting regarding its Phase 3 ROSELLA trial of Lifyorli, a medication combined with nab-paclitaxel for treating platinum-resistant ovarian cancer. The trial demonstrated a 35% reduction in the risk of death for patients treated with Lifyorli compared to those receiving nab-paclitaxel alone. The median overall survival for patients on Lifyorli was 16 months, compared to 11.9 months for the control group. The study included patients with recent taxane exposure and those with a taxane-free interval of six months or less, all showing significant survival benefits. Lifyorli, approved by the FDA in March 2026, is the first selective glucocorticoid receptor antagonist for this cancer type.