US FDA to reconsider decision barring compounded versions of Lilly weight loss drug
The U.S. Food and Drug Administration on Friday agreed to reconsider its recent decision barring drug compounders from ...
Food Safety News8 小时
FDA cracks down on food importers for major safety violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
Daily3 小时
Pfizer Hemophilia drug Hympavzi Receives USFDA Approval
Pfizer announced on Friday that the U.S. Food and Drug Administration has granted approval for its once-weekly injection ...
STAT2 天
In stark reversal, FDA to reconsider removal of Eli Lilly weight loss drug from shortage list
The FDA, in a stark reversal, on Friday said it would reconsider its decision to remove Eli Lilly’s tirzepatide from its ...
US FDA approves Pfizer's drug for rare bleeding disorder
The U.S. Food and Drug Administration approved Pfizer's once-a-week injection for the two main types of a rare bleeding ...
FDA issues recalls on at least 16 food and drug items in September. Here's a list
The FDA has removed the following items from store shelves this September, including pet food, baby powder and Lactaid.
policymed.com3 小时
Mirati Therapeutics Receives Untitled Letter from OPDP for Overstating Cancer Drug Efficacy
Office of Prescription Drug Promotion (OPDP) recently sent an untitled letter to Mirati Therapeutics for claims made by the ...
FDA approves first once-weekly drug treatment regimen for hemophilia
Patients suffering from hemophilia received a "meaningful" advancement on Friday when federal regulators approved the first ...
stockhead on MSN9 小时
Imricor eyes worldwide expansion with progress on US and EU regulatory approval
Imricor Medical Systems (ASX:IMR) is racing through regulatory initiatives supporting new device approvals in the US and ...
Bakery that makes Sara Lee and Entenmann’s pushes back on FDA sesame warning
Bimbo Bakeries USA is pushing back on an FDA warning to stop using labels that say its products contain sesame when they ...
STAT5 天
Q&A: How the FDA is approaching AI in clinical trials and drug development
The FDA's Tala Fakhouri discusses the agency's approach to the regulation of AI in clinical trials in a new interview.