MassDevice

Edwards earns FDA approval for first-of-its-kind size-adjustable pediatric heart valve

The first-of-its-kind valve is designed with the ability to expand as the child grows, reducing the need for repeat ...

FDA seeks scientists and consumer representatives for advisory panels

By Siddhi Mahatole Sept 30 (Reuters) - The US Food and Drug Administration on Wednesday launched a nationwide recruitment ...

US FDA advisers recommend flu vaccine strains for 2027 Southern Hemisphere season

By Sneha S K and Siddhi Mahatole Oct 1 (Reuters) - A panel of advisers to the US FDA on Thursday recommended the virus ...
Cardiovascular Business

FDA approves first heart valve that grows with children

Children with congenital heart disease outgrow their replacement valves, requiring repeat open-heart surgeries. The Autus can ...

Salad Dressing Recall for Potential Salmonella Contamination Classified at FDA’s Highest Warning Level amid Outbreak

Salata Dressings’ jalapeño avocado dressing received an FDA Class I categorization on Tuesday, Sept. 29 ...
BioSpace

FDA Grants Fast Track Designation for TRE-515 in Combination with KRAS G12C Inhibitors for the Treatment of Non-Small Cell Lung Cancer

Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer ...
Cardiovascular Business

Mavacamten gains FDA approval for symptomatic obstructive HCM in pediatric and adult patients

The U.S. Food and Drug Administration (FDA) expanded the indication for Bristol Myers Squibb’s mavacamten (Camzyos) to ...
Health

FDA Announces Peperoncini Recall After Video of Dead Mouse Allegedly Found in Jar Goes Viral

One lot of Mezzetta Golden Greek Peperoncini has been recalled after a viral video allegedly showed a dead mouse in a jar.
Healio

FDA to remove references to animal testing in drug safety regulations

The FDA has issued a final rule that would remove references to animal studies in its drug safety regulations, as part of a ...

The First Home Pregnancy Test Was Approved by the FDA 50 Years Ago. Here’s How the Life-Changing Test Got Its Start

The first at-home pregnancy test was designed by Margaret Crane, who was a freelance graphic designer at the time ...

Edwards Lifesciences Receives FDA Approval for AUTUS Valve, the First Surgical Pulmonary Valve for Pediatric Patients

Edwards Lifesciences (NYSE: EW) today announced that the U.S. Food and Drug Administration (FDA) has approved the AUTUS Size-Adjustable Valve, a surgical pulmonary valve designed specifically for ...

FDA-ordered studies of many drugs, devices on the market are not done

To get drugs and devices out faster, the FDA lets companies conduct studies of safety or efficacy after the products are approved. In many cases, such "postmarket" studies are behind schedule or ...