FDA approves topical cattle drug for screwworm, fever tick

The Exzolt Cattle-CA1 aka Fluralaner topical drug has received conditional approval from federal regulators to prevent and ...

Faulty glucose monitors linked to 7 deaths and more than 700 injuries, FDA warns

The U.S. Food and Drug Administration warned people to stop using certain types of glucose monitor sensors that were linked ...

Mark Cuban seeks Trump’s backing for drug fee relief to spur generics manufacturing

Billionaire Mark Cuban has urged the Trump administration to waive the hundreds of thousands of dollars in regulatory fees ...

US FDA removes longtime director of over-the-counter drugs office

The U.S. Food and Drug Administration is moving Theresa Michele, longtime director of the office of non-prescription drugs, ...

FDA appoints Tracy Hoeg as acting director of drug evaluation center

The U.S. Food and Drug Administration said on Wednesday it has appointed Tracy Beth Hoeg as acting director of the Center for ...

Top FDA drug regulator plans to depart weeks into job

Richard Pazdur had clashed with Trump officials on the legality and pace of their initiatives. His sudden retirement adds to ...

FDA changes heads of drug research and OTC drugs in latest shake-up

The U.S. Food and Drug Administration (FDA) has been rocked by recent changes to several leadership roles while it has ...

FDA chief says Biden administration withheld data on heart risk from Covid vaccines

Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal ...

NRx Pharmaceuticals Announces US Food and Drug Administration (FDA) Receipt of ANDA for KETAFREE™, a Preservative-Free IV Ketamine

FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review.
STAT

Tracy Beth Høeg, Makary aide who investigated Covid vaccines, to lead FDA drug center

Tracy Beth Høeg, a top lieutenant to Food and Drug Administration Commissioner Marty Makary, will be the next leader of the ...

Updated warning: FDA expands warning for cookware brands leaching lead into food

Health officials have identified 21 specific products that leach dangerous levels of lead, including popular brands sold in stores across America.
STAT

FDA to lower number of trials required for approval of drugs, other medical products

The FDA plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration ...