FDA

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

WASHINGTON -- The Food and Drug Administration is alerting health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co. due to “serious concerns with [their] quality.” In a letter released last week, the... Read More

WASHINGTON -- The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and over, making it the first to move beyond emergency use status in the United States. The approval comes as parts... 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

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

WASHINGTON - Dog-owners whose pets are diagnosed with a common form of cancer now have a federally approved treatment option.  That new treatment, the first fully approved drug for canine lymphoma, has shown the conditional track of animal medicine can... Read More

U.S. health regulators on Thursday approved new prescribing instructions that are likely to limit use of a controversial new Alzheimer’s drug. The announcement came through Biogen Inc., the maker of Aduhelm, which stated the update is intended to “clarify” the... Read More

WASHINGTON - The U.S. Food and Drug Administration announced Monday the Pfizer-BioNTech vaccine has been approved for emergency use for adolescents ages 12 to 15 years of age.  “Parents and guardians can rest assured that the agency undertook a rigorous... Read More

WASHINGTON (AP) — The U.S. Food and Drug Administration is expected to authorize Pfizer's COVID-19 vaccine for youngsters ages 12 to 15 by next week, according to a federal official and a person familiar with the process, setting up shots... Read More

WASHINGTON -- A government report released Tuesday raised alarms about the quality of pharmaceuticals made in foreign countries but consumed by Americans. It said the purity of the drugs is questionable because of a lack of adequate inspections by the... Read More

WASHINGTON - On Saturday, the Food and Drug Administration gave emergency authorization to a third coronavirus vaccine. This vaccine, unlike the Pfizer and Moderna vaccines which received emergency authorizations in December, is a single shot vaccine.  Placebo-controlled, randomized studies of... 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

WASHINGTON (AP) — Johnson & Johnson's single-dose vaccine protects against COVID-19, according to an analysis by U.S. regulators Wednesday that sets the stage for a final decision on a new and easier-to-use shot to help tame the pandemic.  The Food... Read More

WASHINGTON - In a public health milestone, the Food and Drug Administration announced on Tuesday that it approved a record setting amount of novel medical devices in 2020.  In 2020, the FDA’s Center for Devices and Radiological Health gave the... Read More

WASHINGTON - The U.S. Supreme Court lifted a nationwide injunction Tuesday that had prevented the federal government from enforcing a rule that required women to see a health care professional in person before she'd be given access to a so-called... Read More

WASHINGTON (AP) — A government advisory panel endorsed a second COVID-19 vaccine Thursday, paving the way for the shot to be added to the U.S. vaccination campaign. The Food and Drug Administration is expected to follow the recommendation for the... Read More

WASHINGTON — The first COVID-19 test that can be performed entirely from home was cleared by U.S. regulators on Tuesday, and it can be acquired without a prescription. While availability initially will be limited, the new test and others in... Read More

Moderna Inc.’s vaccine is safe and effective for preventing COVID-19, U.S. regulators said, clearing the way for a second shot to quickly gain emergency authorization and add to the country’s sprawling immunization effort. The Food and Drug Administration’s staff said... Read More

WASHINGTON - Under intense pressure from the White House, the Food and Drug Administration dramatically moved up its timeline, issuing an emergency authorization for Pfizer's COVID-19 vaccine on Friday. The agency had initially planned to finalize its authorization on Saturday,... Read More