The FDA has issued Class I recalls for chocolate products due to undeclared allergens and contamination—posing serious health ...

The panelists said that vaginal creams and other localized therapies for menopause are safe and vastly underused by women who could benefit.

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...

Dr. Marty Makary, the agency’s commissioner, said too many women avoid hormone therapy because the risks have been overstated ...

The FDA said on its website: "Pregnant women and their unborn or newborn baby, adults over the age of 65, and those with weakened immune systems, are all considered to be high-risk groups that are ...

Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.

The product was shipped to one customer in North Carolina, according to the FDA. A Class I recall was issued for blueberries produced by Alma Pak International in Atlanta, Georgia.

The FDA released its risk classification on June 16. According to the FDA, the recall , which was voluntary and initiated by the company, was prompted by the use of cucumbers that may be ...

The FDA turned down Sanofi’s Dupixent application in this indication in 2023. The latest regulatory decision for the product is based on a resubmission that included data from another Phase 3 study.

In this week’s edition of InnovationRx, we look at the FDA's new rules on Covid-19 vaccines, Novartis’s acquisition strategy, Medtronic’s diabetes spinoff, Regeneron’s purchase of 23AndMe ...