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FDA Issues Warning to Medline Over Persistent Contamination Issues

FDA Issues Warning to Medline Over Persistent Contamination Issues

FDA Issues Warning to Medline Over Persistent Contamination Issues
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ADC Therapeutics Faces Setback as Lymphoma Drug Trial Results in 27 Deaths

ADC Therapeutics Faces Setback as Lymphoma Drug Trial Results in 27 Deaths

ADC Therapeutics Faces Setback as Lymphoma Drug Trial Results in 27 Deaths
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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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FDA Issues Guidance to Accelerate Cell and Gene Therapy Development

FDA Issues Guidance to Accelerate Cell and Gene Therapy Development

The FDA has released draft guidance aimed at expediting the development of cell and gene therapies (CGT) by allowing developers to utilize existing scientific knowledge to streamline regulatory submissions. This initiative is part of a broader effort by the FDA to reduce barriers for CGT sponsors, particularly for diseases with limited treatment options. The guidance encourages the use of publicly available data and established knowledge, such as chemistry, manufacturing, and controls (CMC) data, to facilitate faster approval processes. The FDA's acting director of the Center for Biologics Evaluation and Research, Karim Mikhail, emphasized the importance of this guidance in delivering safe and effective therapies to patients with rare and life-threatening diseases.
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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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New Pancreatic Cancer Drug Daraxonrasib Shows Promise in Doubling Survival Rates

New Pancreatic Cancer Drug Daraxonrasib Shows Promise in Doubling Survival Rates

A new drug, daraxonrasib, is showing significant promise in improving survival rates for pancreatic cancer patients. During the 2026 American Society of Clinical Oncology annual meeting, Dr. Brian Wolpin presented findings that daraxonrasib nearly doubled survival rates for patients in clinical trials. Pancreatic cancer, known for its rapid lethality, is the third-leading cause of cancer deaths in the U.S., claiming nearly 53,000 lives annually. The drug targets KRAS mutations, which are prevalent in over 90% of pancreatic cancer cases. The FDA has granted daraxonrasib expanded access, and it is on a fast track for full approval. The drug is also being studied for other solid-tumor cancers, with promising preliminary results.
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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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FDA Recalls Ice Pops in Four States Due to Allergen Concerns

FDA Recalls Ice Pops in Four States Due to Allergen Concerns

The U.S. Food and Drug Administration (FDA) has announced a recall of ice pops sold in New Jersey, New York, Pennsylvania, and Connecticut. The recall involves 3.7-oz packages of D'Dioses Fruit Pops, which may contain undeclared allergens such as milk, Yellow #5, Red #40, pecans, and pistachios. The recall was initiated following an FDA inspection that identified the need for improved manufacturing processes to prevent allergen cross-contact. The company has since updated its allergen-control procedures. Consumers who purchased the affected products are advised to return them for a full refund. No illnesses have been reported in connection with the recall.
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Exploration of Nitric Oxide Supplements Highlights Mixed Benefits for Fitness and Health

Exploration of Nitric Oxide Supplements Highlights Mixed Benefits for Fitness and Health

Exploration of Nitric Oxide Supplements Highlights Mixed Benefits for Fitness and Health
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AstraZeneca Seeks FDA Approval for Camizestrant in Breast Cancer Treatment Despite Advisory Committee Setback

AstraZeneca Seeks FDA Approval for Camizestrant in Breast Cancer Treatment Despite Advisory Committee Setback

AstraZeneca Seeks FDA Approval for Camizestrant in Breast Cancer Treatment Despite Advisory Committee Setback
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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 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