FDA

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

WASHINGTON -- A federal panel of outside experts on Thursday endorsed a coronavirus vaccine from Pfizer and BioNTech, recommending that the Food and Drug Administration move forward with emergency authorization. President-elect Joe Biden responded with a statement saying, “Today’s approval... Read More

WASHINGTON — The Food and Drug Administration will not automatically authorize emergency use of coronavirus vaccines before completing a rigorous independent review, despite heightened expectations that two vaccine candidates will be available to Americans this month, Dr. Stephen Hahn, FDA commissioner, told McClatchy in... Read More

Moderna Inc. requested clearance for its coronavirus vaccine in the U.S. after a new analysis showed the vaccine was highly effective in preventing COVID-19, with no serious safety problems. A Moderna spokesman said in a text message late Monday afternoon that its application for an... Read More

The U.S. Food and Drug Administration has officially approved remdesivir as a treatment for coronavirus, drug manufacturer Gilead Sciences announced Thursday. The Ebola drug was already being used to treat patients under an emergency-use authorization issued in May, but the latest FDA action makes... Read More

WASHINGTON — The Food and Drug Administration issued long-awaited guidance Tuesday on the data it expects from drug companies seeking emergency authorization of COVID-19 vaccines, rejecting White House pressure for lower standards intended to push out vaccines quickly. The 18-page... Read More

ATLANTA — The federal government’s top infectious disease official attempted to reassure the public Thursday that he’ll support safety standards set by federal officials for any COVID-19 vaccines and their work won’t be swayed by politics. “If (U.S. Food and... Read More

FAIRLESS HILLS, PA (AP) — Investors fled drug developer BioMarin in droves on Wednesday, driving shares down by a third after U.S. regulators rejected the company’s potentially game-changing hemophilia A gene therapy over concerns it might not really be a... Read More

WASHINGTON - The Food and Drug Administration revoked its emergency authorization of hydroxychloroquine and chloroquine for treating COVID-19 as evidence mounts that the drugs don't work and can cause serious side effects. “We’ve made clear throughout the public health emergency... Read More

WASHINGTON - The Food and Drug Administration Tuesday approved the first diagnostic test for the coronavirus that allows people to collect their sample at home -- a development that could greatly expand testing options in states fighting to corral the... Read More

WASHINGTON — The Food and Drug Administration asked a federal judge to grant a 120-day delay for a deadline for e-cigarette manufacturers to submit applications to keep their products on the market. Citing “the exceptional circumstances presented by the global... Read More

The federal government has issued an emergency order allowing its coronavirus test to be used by state health labs nationwide, speeding up efforts to detect and contain new cases of the mysterious new illness. Since the first cases of the... Read More