FDA approval

Increasingly, the FDA is asking drugmakers to remove unproven uses from older drugs that haven't delivered on early results. And drugmakers seeking accelerated approvals are facing tougher hurdles.

Now that the Food and Drug Administration has fully approved the Pfizer-BioNTech vaccine against COVID-19, South Florida health care experts hope to see more vaccine mandates and more people getting their shots.

The Food and Drug Administration greenlights the biotech firm's vaccine for emergency use in the U.S. The move bolsters a vast inoculation effort that's already underway.

Advisers to the Food and Drug Administration voted 20-0 to recommend that the agency authorize Moderna's vaccine for emergency use during the pandemic. There was a single abstention.

The drug is a combo of two antibodies to enhance the chances it will prove effective. It's an experimental medicine that President Trump was given when he was sickened last month.

President Donald Trump is among those who have been treated with remdesivir, and FDA-approval could widen access to more patients.

A panel of doctor and scientists raised questions about the expedited regulatory path the Food and Drug Administration is considering for COVID-19 vaccines.

Regional blood donation center OneBlood will begin collecting plasma from COVID-19 survivors as a possible treatment for future patients.An experimental…

Changes in the way the Food and Drug Administration reviews new medicines means that there are more cures and treatments on the market. But there's also less proof the drugs are safe and effective.

The condom, the pill and now, the smartphone? Natural Cycles, a mobile fertility app, this month became the first ever digital contraceptive device to...