Health Sep 29 FDA plans to regulate thousands of lab tests that have long skirted oversight The Food and Drug Administration says it plans to begin regulating laboratory-based medical tests. It's a multibillion-dollar industry that regulators say poses a growing risk to patients.
Health Sep 12 Popular nasal decongestant doesn’t actually relieve congestion, FDA advisers say The Food and Drug Administration convened an expert panel to review the latest data on phenylephrine. That's found in over-the-counter versions of Sudafed, Dayquil and other cold medicines sold on pharmacy shelves.
Health Aug 04 FDA approves first postpartum depression pill The Food and Drug Administration approved the drug, called Zurzuvae, for adults experiencing severe depression related to childbirth or pregnancy. It's taken once a day for 14 days.
Nation Jul 13 FDA approves first over-the-counter birth control pill U.S. officials have approved the first over-the-counter birth control pill, a major change that will broaden access for women and teenagers.
Health Jul 06 Alzheimer’s drug Leqembi has full FDA approval, clearing way for Medicare coverage The FDA gave it conditional approval in January based on early results suggesting the drug could modestly slow cognitive decline.
Nation Jun 27 Thousands of unauthorized vapes are pouring into the U.S. despite FDA crackdown The number of different electronic cigarette devices sold in the U.S. has nearly tripled to over 9,000 since 2020, driven almost entirely by a wave of unauthorized disposable vapes from China, according to data obtained by The Associated Press.
Health Jun 22 First gene therapy for deadly form of muscular dystrophy gets FDA approval for young children The treatment from Sarepta Therapeutics was approved Thursday for children ages 4 and 5 with Duchenne muscular dystrophy, a rare muscle-wasting disease that causes early death.
Health Jun 22 FDA warns stores to stop selling fruity disposable e-cigarettes U.S. regulators have sent warning letters to dozens of retailers selling fruity disposable e-cigarettes, including the current best-selling brand, Elf Bar.
Health May 25 COVID pill Paxlovid gets full FDA approval after over a year of pandemic emergency use Thursday's action means the drug has now been fully vetted by the U.S. government and can remain on the market indefinitely. Millions of Americans have received Paxlovid since it was granted emergency authorization in late 2021.
Health May 11 FDA relaxes blood donation guidelines for men who have sex with men The new approach does away with a requirement that men who have sex with men abstain from sex for three months to prior to giving blood.