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MedPage Today2h
First Targeted Therapy for Exon 20 Insertions in NSCLC Wins FDA Accelerated Approval
The FDA granted accelerated approval to the tyrosine kinase inhibitor sunvozertinib (Zegfrovy) for advanced non-small cell ...
US FDA approves KalVista's oral swelling disorder drug, shares rise
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, the first on-demand oral ...
FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
ALS Community Files Citizens’ Petition asking FDA to Approve NurOwn Stem Cell Therapy
New and Unprecedented Survival, Respiratory, and Biomarker Data Prove that NurOwn Helps People with ALS Live Longer and Live ...
Nationwide gummies recall update as FDA issues highest risk warning
Vita Warehouse Corp. recalled more than 40,000 bottles of Vitamin B12 supplements for possible undeclared presence of peanut.
Medical groups sue HHS, RFK Jr. over 'unlawful' vaccine changes
Several major medical organizations filed a lawsuit against the HHS and Secretary Robert F. Kennedy Jr. on Monday over what ...
Targeted Oncology3h
FDA Approves SIR-Spheres Y-90 for First-Line Use in Unresectable HCC
Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted ...
Watch Milestone Pharmaceuticals For (Likely) Upcoming FDA Approval For Cardamyst
Milestone Pharmaceuticals Inc. is a strong buy under $2 with FDA approval for Cardamyst expected in 2026, offering unique ...
The American Journal of Managed Care4h
FDA Approves Sunvozertinib in Non–Small Cell Lung Cancer
The treatment marks the only targeted oral treatment in patients with non–small cell lung cancer with epidermal growth factor ...
After delay, Kalvista wins FDA OK for drug to treat rare swelling disorder
The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an ...
Applied Clinical Trials Online1h
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, ...
STAT7h
Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...