Food and Drug Administration

WASHINGTON — An abortion pill previously available only from a certified doctor, clinic or two online pharmacies will soon be obtainable at local pharmacies with a prescription, the Food and Drug Administration announced Tuesday. Mifepristone is the first of two... Read More

WASHINGTON — The Food and Drug Administration on Thursday amended its emergency use authorizations for the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines, saying the shots are safe to administer to children as young as 6 months old. “More children... Read More

WASHINGTON — Sens. Patty Murray, D-Wash., and Richard Burr, R-N.C., have struck a deal on language that will allow the reauthorization of the Food and Drug Administration’s user fee program to move forward as part of the continuing resolution Congress... Read More

TAMPA, Fla. — Florida's governor announced Wednesday his state is suing the Food and Drug Administration to speed up permission to import drugs from Canada. Canadian drugs for diabetes, hepatitis C and other common illnesses are less expensive than most... Read More

WASHINGTON — The Food and Drug Administration on Wednesday authorized updated COVID-19 booster shots specifically targeting a subvariant of omicron. The agency approved two options aimed at the BA.5 subvariant of omicron that is now dominant in the U.S.: one... Read More

WASHINGTON — Pfizer and its German partner, BioNTech, asked the Food and Drug Administration Monday to authorize COVID booster shots that target the omicron BA.4 and BA.5 subvariants for people aged 12 and older. The request came less than a... Read More

WASHINGTON — More than 4.8 million cans of infant formula will be shipped to U.S. retailers from an Australian manufacturer beginning in August, the Food and Drug Administration announced Friday. The formula is being sourced from Care A2+, an Australian-owned... Read More

WASHINGTON — A federal appeals court on Friday stayed the Food and Drug Administration's ban on sales of Juul Labs Inc's e-cigarettes, after the company appealed the agency's order on the grounds the ban would cause it "irreparable harm." The... Read More

WASHINGTON — The Food and Drug Administration on Thursday ordered Juul Labs to pull its electronic cigarettes from the U.S. market, a move intended to curb a multibillion-dollar industry blamed for sparking a national surge in teen vaping.  "Today's action... Read More

WASHINGTON — A bill introduced by Sen. Edward Markey, D-Mass., on Thursday would tighten the rules for companies seeking pre-market approval for chemicals included in food. The legislation would also direct the secretary of the U.S. Department of Health and... Read More

WASHINGTON — Members from the Senate Health, Education, Labor and Pensions Committee released a draft of the legislative package to reauthorize user fee agreements for the U.S. Food and Drug Administration on Tuesday, which are set to end on Oct.... Read More

WASHINGTON — At a White House briefing Tuesday, Dr. Ashish Jha, the new White House Coronavirus Response Coordinator, detailed how the U.S. plans to ramp up supplies of Paxlovid, an oral antiviral treatment which is used to prevent severe illness... Read More

WASHINGTON — Sen. Patty Murray, D-Wash., chair of the Senate Health, Education, Labor and Pensions Committee, issued a letter this week to the U.S. Food and Drug Administration Commissioner Robert Califf, requesting the FDA step up efforts to ensure the... Read More

WASHINGTON — Bypassing its review panel of independent experts, the Food and Drug Administration authorized a fourth dose of the Pfizer and Moderna coronavirus vaccine for people 50 and older. The authorization for the fourth shot comes as an omicron... Read More

WASHINGTON — The Senate on Tuesday approved Robert Califf’s nomination to be the new head of the Food and Drug Administration. The 50-46 vote came just over 12 hours after the chamber cast a decidedly narrow vote to limit debate... Read More

WASHINGTON — Yamo Pharmaceuticals recently enrolled its first patient in a phase 2 clinical trial that may result in medicines able to treat the core behaviors of autism spectrum disorder. “There are 20 million or more people with autism around... Read More

WASHINGTON — The U.S. Food and Drug Administration has approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine, known as Spikevax, was approved after finding the vaccine met rigorous standards for... Read More

WASHINGTON — The U.S. Food and Drug Administration recently partnered with Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency to issue guiding principles to align efforts and standards for artificial intelligence and machine learning medical device development... Read More

WASHINGTON — The Food and Drug Administration on Friday authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 to 11. “As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting... Read More

WASHINGTON (AP) — U.S. health experts are expected to recommend COVID-19 vaccine boosters for all Americans, regardless of age, eight months after they received their second dose of the shot, to ensure lasting protection against the coronavirus as the delta... Read More

The Food and Drug Administration has authorized the use of an additional dose of the Pfizer-BioNTech and Moderna COVID-19 vaccines for organ transplant recipients diagnosed as immunocompromised. Thursday’s announcement came ahead of a meeting today of the Centers for Disease... Read More

The underlying algorithms for an app that can mass detect COVID-19 through audio are not quite ready yet, researchers say. COVID-19 has a distinct effect on the audio produced by infected people, which has enticed researchers to explore using it... Read More

As the Delta variant continues to spread, COVID cases surge among the unvaccinated, and rates of new vaccinations decline, the U.S. Food and Drug Administration is receiving pressure from President Joe Biden to approve a COVID vaccine. Biden recently said... Read More

WASHINGTON -- The Food and Drug Administration announced they are working toward issuing proposed product standards within the next year to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars.  Menthol flavoring has been known... Read More

SILVER SPRING, Md. — The Food and Drug Administration on Monday granted its approval to aducanumab, an Alzheimer’s treatment developed by Biogen for use in patients, despite mixed clinical trial results for the drug.  Prescribed under the brand name “Aduhelm,”... Read More

WASHINGTON- The Biden Administration's 2022 budget, released at the end of last week, seeks significant spending increases for the U.S. Food and Drug Administration.  The fiscal year 2022 budget request sets out $6.5 billion for the FDA, an increase of... Read More

The White House is stepping up its efforts to encourage the parents of adolescents age 12-15 to get their kids vaccinated against COVID-19.Earlier this week, the Food and Drug Administration expanded the emergency use authorization for the Pfizer BioN-Tech vaccine... Read More

MISSION, Kan. (AP) — After more than a year of fretting over her 13-year son with a rare liver disease, Heather Ousley broke into tears when she learned that he and millions of other youngsters could soon be eligible for... Read More

WASHINGTON - The Food and Drug Administration issued an emergency authorization for a non-prescription, over the counter nostril test for coronavirus, the agency announced on Friday.  It's the first over the counter molecular test they have authorized for use without... Read More

WASHINGTON - The Food and Drug Administration has relaxed the rules around storage and transportation for some coronavirus vaccines in order to speed up the vaccine rollout. Frozen vials of Pfizer-BioNTech's coronavirus vaccine will be allowed to be kept at... Read More