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.
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 ...
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, shares rise
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, the first on-demand oral ...
BioPharma Dive6m
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 ...
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 ...
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 ...
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 ...
Targeted Oncology1h
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 ...
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 ...
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 ...
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 ...