Latest U.S. Food and Drug Administration News
Elon Musk's brain implant company Neuralink says it has US approval to begin trials in people
Elon Musk’s brain implant company Neuralink says it's gotten permission from U.S. regulators to begin testing its device in people. The company made the announcement on Twitter Thursday evening but has provided no details about a potential study, which was not listed on the U.S....
COVID pill Paxlovid gets full FDA approval after more than a year of emergency use
WASHINGTON (AP) — Pfizer received full approval on Thursday for its COVID-19 pill Paxlovid that's been the go-to treatment against the coronavirus. More than 11 million prescriptions for Paxlovid have been dispensed since the Food and Drug Administration allowed emergency use in...
New nasal spray to reverse fentanyl and other opioid overdoses gets FDA approval
WASHINGTON (AP) — U.S. health regulators on Monday approved a new easy-to-use version of a medication to reverse overdoses caused by fentanyl and other opioids driving the nation’s drug crisis. Opvee is similar to naloxone, the life-saving drug that has been used for decades to...
FDA advisers back RSV vaccine for pregnant women that protects their newborns
WASHINGTON (AP) — A first-of-its-kind RSV vaccine for pregnant women guards their newborns against the scary respiratory virus -– and federal health advisers on Thursday backed Pfizer's shot despite some lingering questions. RSV fills hospitals with wheezing babies each fall and...
Recalled Gerber baby formula was sent to US retailers after recall began, wholesaler says
NEW YORK (AP) — An infant formula recalled over potential bacteria contamination was distributed to retailers across eight states after the recall began, according to a release published by the U.S. Food and Drug Administration this week. Perrigo Co. issued a voluntary March recall...
New menopause drug for hot flashes gets FDA approval
WASHINGTON (AP) — U.S. health regulators on Friday approved a new type of drug for women dealing with uncomfortable hot flashes caused by menopause. The Food and Drug Administration approved the once-a-day pill from Astellas Pharma to treat moderate-to-severe symptoms, which can...
New blood donation rules allow more gay men to give in US
WASHINGTON (AP) — Gay and bisexual men in monogamous relationships can give blood in the U.S. without abstaining from sex under updated federal health guidelines that focus on donors’ behavior, not their sexual orientation. The Food and Drug Administration guidelines finalized...
A skin patch to treat peanut allergies? Study in toddlers shows promise
WASHINGTON (AP) — An experimental skin patch is showing promise to treat toddlers who are highly allergic to peanuts — training their bodies to handle an accidental bite. Peanut allergy is one of the most common and dangerous food allergies. Parents of allergic tots are...
Republican Virginia Attorney General Miyares defends staying out of abortion pill case
RICHMOND, Va. (AP) — Virginia Attorney General Jason Miyares has defended his decision not to join most of his Republican counterparts around the country in supporting a lawsuit challenging the safety and approval of the abortion medication mifepristone. In a wide-ranging interview...
FDA panel backs over-the-counter sales of birth control pill
WASHINGTON (AP) — Federal health advisers said Wednesday that a decades-old birth control pill should be sold without a prescription, paving the way for a likely U.S. approval of the first over-the-counter contraceptive medication. The panel of FDA advisers voted unanimously in...
