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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 ...
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 ...
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 ...
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.
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.
FDA vaccine official restricted COVID vaccine approvals against agency advice
A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...
The American Journal of Managed Care1h
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 ...
FDA approves KalVista’s Ekterly for hereditary angioedema
The US Food and Drug Administration (FDA) has approved KalVista Pharmaceuticals' Ekterly (sebetralstat) as the first and only ...
BioPharma Dive9m
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 ...