News

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.
MedPage Today4h
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 ...
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 ...
STAT9h
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 ...
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 Oncology5h
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 ...
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 ...
BioPharma Dive5h
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 ...
RFK Jr.'s FDA officials overrode career staff to limit COVID shots
The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.
STAT9h
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 ...
Targeted Oncology7h
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 ...
FDA Issues Most-Serious Risk Warning for Cucumber Recall
Consumption of impacted products could cause "serious adverse health consequences or death," according to the FDA.