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.
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 ...
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 ...
STAT3h
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 ...
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 ...
Fierce Pharma2h
KalVista bounces back from FDA delay with approval for oral rare disease med Ekterly
After facing an unexpected regulatory delay last month, KalVista Pharmaceuticals has leapt into the commercial realm with the ...
PharmExec1h
FDA Grants Priority Review to Merck’s Winrevair Label Update for Pulmonary Arterial Hypertension to Reflect Risk Reduction Benefits
Results from the Phase III ZENITH trial show that patients treated with Winrevair (sotatercept-csrk) for pulmonary arterial ...
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.
The American Journal of Managed Care54m
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 ...
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.
STAT3h
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'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 ...