The Food and Drug Administration (FDA) has accepted for review Milestone’s response to issues raised in a Complete Response Letter (CRL) for etripamil nasal spray (Cardamyst ™ ), an investigational ...

The sandwiches were available at micro markets and vending machines in all of Ohio, Eastern Indiana and Northern Kentucky.

A labeling mistake has led to a nationwide recall of four different types of Ritz peanut butter cracker sandwich cartons, ...

AirLife and Vyaire are recalling specific infant breathing support systems due to a potentially dangerous defect that could ...

Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...

The new dosing schedule with a more gradual titration significantly lowered incidence of ARIA-E in the TRAILBLAZER-ALZ 6 trial.

The U.S. Food and Drug Administration has granted full approval for Moderna's MRNA.O COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years who are at an increased risk of the disease, ...

Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...

The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition, the ...

The FDA granted fast track designation to TRE-515 plus radioligand therapy for treating PSMA-positive metastatic ...

Moderna's COVID-19 vaccine has received full approval from the U.S. Food and Drug Administration (FDA) for use in children ...