News

FDA to Share Rejection Letters Drugmakers Often Keep Secret
The head of the US Food and Drug Administration said the agency will start publishing the rejection letters that companies ...
FDA Issues Highest Risk Warning for Nationwide Chocolate Recall
Weaver Nut Company, Inc. announced a recall for specific lots of its semi-sweet chocolate nonpareils on June 17 due to the undeclared presence of milk.
FDA approves Purespring’s application for Phase I/II trial of IgAN treatment
The trial is scheduled to commence in the fourth quarter of this year, with subject recruitment in both Europe and the US.
Merck: FDA to Review Doravirine/Islatravir Regimen in HIV-1 Infection
Merck on Thursday said the application covers the investigational, once-daily, oral two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy. The ...
US FDA approves gradual dosing for Lilly Alzheimer's drug
The U.S. Food and Drug Administration approved changing the prescribing information for Eli Lilly's Alzheimer's drug Kisunla to allow more gradual dosing to lower the risk of a potentially dangerous ...
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 ...
STAT2d
Inside the staff exodus and tanking morale that threaten Makary’s FDA
The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s work, current ...
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 ...
FDA Suspends Mumbai MLA Canteen Caterer's License After Shiv Sena Leader Sanjay Gaikwad's Slapgate Over 'Stale Food'
Mumbai: The Maharashtra Food and Drugs Administration (FDA) has suspended the license of Ajanta Caterers, the service ...
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 treatment for a type of hereditary swelling disorder, sending its shares ...
FDA Upgrades Trader Joe’s Cheese Recall to Highest Risk Level Due to 'Deadly' Listeria
Trader Joe’s has announced a recall of Face Rock Creamery’s Vampire Slayer Garlic Cheddar Cheese Curds due to potential ...
FDA Issues Highest Risk Warning For Cucumber Recall
Fuentes Farms LLC announced a voluntary recall of 71 boxes of fresh cucumbers on June 13 due to potential salmonella ...