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MedPage Today27m
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 ...
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.
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 ...
US FDA approves KalVista Pharma's 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 ...
Targeted Oncology1h
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 ...
BioPharma Dive1h
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 ...
STAT5h
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 ...
Mustang Bio (MBIO) Stock Explodes 260% After FDA Grants Key Cancer Drug Designation
Mustang Bio shares are trading sharply higher Monday afternoon. The FDA granted Orphan Drug Designation to its cell therapy, ...
Targeted Oncology3h
FDA Clears Oncomine Dx Express Test for Sunvozertinib in EGFR Exon 20+ NSCLC
The FDA approves a rapid test for identifying patients with NSCLC eligible for sunvozertinib, enhancing timely, precision ...
STAT5h
Pharmalittle: We’re reading about FDA morale, a U.S.-Swiss trade deal on pharma levies, and more
The steady erosion of experienced staff is slowly compromising FDA work and low morale is pushing more workers to the exit ...
US FDA approves KalVista Pharma's swelling disorder drug
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug for a type of hereditary ...