-
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.
-
An NPR investigation found stalled confirmatory trials and lax enforcement are plaguing the FDA's accelerated approval of drugs for urgent medical needs.
-
When a new drug is up for FDA approval, trials may be held not only in the U.S. but other countries too. A study looks at global availability after approval. Big Pharma disagrees with the findings.
-
This is the first new drug approved for Alzheimer's disease since 2003. It's the first to show significant progress against the sticky brain plaques that are the hallmark of Alzheimer's disease.
-
The FDA has approved giving the vaccine to ages 12 and older. By when and where, and what about younger kids? You have questions. We have answers.
-
Pfizer said in late March that clinical trials found "100% efficacy and robust antibody responses" to the coronavirus in 12- to 15-year-olds.
-
Gov. DeSantis said he thought HHS, which signed an agreement with Pfizer, would allocate based on states’ so-called at-risk populations. Instead, he said the feds “basically did it on a population basis.”
-
A newly approved drug can extend the lives of children with progeria, a rare disorder that causes rapid aging. The drug is the result of one family's effort to help a child with the fatal condition.
-
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.
-
The Lucira COVID-19 All-In-One Test Kit is expected to provide results in 30 minutes or less. Its approval could help alleviate the strain on the nation's precarious coronavirus testing system.