FDA, Eli Lilly
In win for compounders, FDA will review its decision to put Eli Lilly's tirzepatide on shortage list
In accepting the FDA’s motion, U.S. District Judge Mark Pittman put on hold a lawsuit filed by the Outsourcing Facilities Association (OFA), which called the FDA’s decision to remove tirzepatide from the shortage list a “reckless and arbitrary decision—lacking any semblance of lawful process.”
The agency agreed in court to allow compounding companies to continue producing copycat versions of Lilly’s fast-selling medicines while it reevaluates its recent decision to declare the drugs back in ...
The reconsideration follows an Oct. 11 lawsuit that prompted U.S. District Judge Mark Pittman to temporarily halt legal proceedings to give the FDA time to reassess its ruling.
The recall was originally announced Sept. 6 by the Centers for Disease Control and Prevention. It was upgraded Sept. 30 to ...
CMR Surgical obtained a de novo clearance from the FDA for its Versius surgical system, finally allowing its modular, ...
Patients suffering from hemophilia received a "meaningful" advancement on Friday when federal regulators approved the first ...
Healgen Scientific's combined COVID-19 and flu test gives people a new way to check what's causing their symptoms, FDA says.
The U.S. Food and Drug Administration (FDA) has given the highest risk classification to several recalled animal feed ...
Eggs sold in three states have been recalled due to possible salmonella contamination. Here's what consumers need to know ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
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