FDA

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 (AP) — The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA... Read More

WASHINGTON — A panel of advisors to the Food and Drug Administration on Tuesday declined to recommend approval of a new heart drug created by biotech firm Cytokinetics, finding the benefits of the drug do not outweigh its risks. The... 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 (AP) — Expedited drug approvals slowed this year as the Food and Drug Administration's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders. With less than a month remaining in... Read More

WASHINGTON — The Food and Drug Administration has conditionally approved Panoquell-CA1 for the management of clinical signs associated with acute onset of pancreatitis in dogs.  Panoquell-CA1 is an injectable drug intended for use while the dog is hospitalized for treatment... Read More

WASHINGTON — The Food and Drug Administration and the Veterans Health Administration have entered into a new level of collaboration intended to help accelerate American medical device innovation.  Under the auspices of a memorandum of understanding signed last week, the... Read More

WASHINGTON (AP) — A panel of federal health advisers voted Wednesday to recommend approval for an experimental drug to treat Lou Gehrig’s disease, a remarkable turnaround for the much-debated medication that was previously rejected by the same group earlier this year. The... Read More

WASHINGTON — The Food and Drug Administration issued a final rule Tuesday morning that promises to provide millions of Americans with access to lower cost, over-the-counter hearing aids. The action, which follows an executive order signed by President Joe Biden... Read More

WASHINGTON — The Food and Drug Administration on Friday gave its approval for COVID-19 vaccines for children age 5 and younger.  The shots could start as early as next week if, as expected, the Centers for Disease Control and Prevention... Read More

WASHINGTON — The Senate Committee on Health, Education, Labor and Pensions voted on Tuesday to advance legislation that will reauthorize a number of important U.S. Food and Drug Administration user fee programs. “This is the most important, comprehensive FDA legislation... Read More

SILVER SPRING, Md. — Watch what you eat, or at least what your food is exposed to. The Food and Drug Administration on Thursday amended its food additive regulations to no longer provide for previously authorized chemicals to be used... Read More

WASHINGTON — Members of the Senate Committee on Health, Education, Labor and Pensions wanted to know why the U.S. Food and Drug Administration is requesting nearly double its annual budget while failing to meet many of the goals tied to... 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

More than half of U.S. abortions are now done with pills rather than surgery, an upward trend that spiked during the pandemic with the increase in telemedicine, a report released Thursday shows. In 2020, pills accounted for 54% of all... Read More

The U.S. Food and Drug Administration last month authorized the marketing of two combusted, filtered cigarettes as modified risk tobacco products. The products, 22nd Century Group Inc.’s “VLN (Very Low Nicotine) King” and “VLN Menthol King,” which produce all of the smoke... Read More

WASHINGTON (AP) — The Food and Drug Administration on Thursday permanently removed a major obstacle for women seeking abortion pills, eliminating a long-standing requirement that they pick up the medication in person. Millions of American women will now be able... Read More

WASHINGTON — An advisory panel for the Food and Drug Administration narrowly approved the use of a COVID-19 pill manufactured by Merck. If the agency accepts the recommendation, molnupiravir would be the first drug Americans could be prescribed and take... 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) — Federal regulators are expected to authorize the mixing and matching of COVID-19 booster shots this week in an effort to provide flexibility for those seeking to maintain protection against the coronavirus. The upcoming announcement by the Food... Read More

WASHINGTON (AP) — U.S. health advisers on Friday tackled who should get boosters of Johnson & Johnson's single-shot COVID-19 vaccine and when — and whether using a competing brand for the second dose might provide better protection. The push for... Read More

U.S. health advisers said Thursday that some Americans who received Moderna's COVID-19 vaccine should get a half-dose booster to bolster protection against the virus. The panel of advisers to the Food and Drug Administration voted unanimously to recommend a booster... Read More

NEW YORK (AP) — Food companies are coming under renewed pressure to use less salt after U.S. regulators spelled out long-awaited guidelines aimed at reducing sodium levels in dozens of foods including condiments, cereals, french fries and potato chips. The... Read More

WASHINGTON  -- The Food and Drug Administration late Tuesday authorized the marketing of an electronic cigarette in the United States. A groundbreaking development in a long running debate over the healthfulness of such products. Specifically, the FDA granted the R.J.... Read More

WASHINGTON (AP) — With many Americans who got Pfizer vaccinations already rolling up their sleeves for a booster shot, millions of others who received the Moderna or Johnson & Johnson vaccine wait anxiously to learn when it's their turn. Federal... Read More

WASHINGTON (AP) — Straining under a pandemic workload and battered by a string of public controversies, one of the leading agencies in the government's fight against COVID-19 is finally on the verge of getting a new commissioner. After nearly nine... Read More

WASHINGTON (AP) — Pfizer has submitted research to the U.S. Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children but the shots may not be available until November. The company said Tuesday it provided health regulators... Read More

WASHINGTON - A Food and Drug Administration advisory panel voted unanimously Friday to recommend emergency use authorization of a booster dose of Pfizer-BioNTech COVID-19 vaccine six months after full vaccination in people 65 and older and those at high risk... Read More

The average person doesn't need a COVID-19 booster yet, an international group of scientists — including two top U.S. regulators — wrote Monday in a scientific journal. The experts reviewed studies of the vaccines' performance and concluded the shots are... Read More

WASHINGTON — With the public school year already underway around the country, the Food and Drug Administration is not taking chances when it comes to making COVID-19 vaccinations available to children younger than 12 years old. Acting FDA Commissioner Janet... Read More