Latest U.S. Food and Drug Administration News

Report: Dough company didn't report tampering with screws

Oct. 27, 2020 2:06 PM EDT

PORTLAND, Maine (AP) — A Maine company that produces pizza dough and is the focus of a tampering investigation received three complaints about screws in the dough that were never reported to the Food and Drug Administration, a newspaper reported Tuesday. Scarborough-based It’ll Be Pizza produced the...

FILE - In this Wednesday, June 24, 2020 file photo, a volunteer receives an injection at the Chris Hani Baragwanath hospital in Soweto, Johannesburg, as part of Africa's first participation in a COVID-19 vaccine trial developed at the University of Oxford in Britain in conjunction with the pharmaceutical company AstraZeneca. On Friday, Oct. 23, 2020, AstraZeneca Inc. announced that the Food and Drug Administration is letting it resume testing of its COVID-19 vaccine candidate in the U.S. (Siphiwe Sibeko/Pool via AP)

AstraZeneca, J&J resuming US tests of COVID-19 vaccines

Oct. 23, 2020 6:31 PM EDT

Two drugmakers announced Friday the resumption of U.S. testing of their COVID-19 vaccine candidates. Testing of AstraZeneca’s vaccine candidate had been halted since early September, while Johnson & Johnson’s vaccine study was paused at the beginning of last week. Each company had a study...

FILE - In this July 27, 2020, file photo, Nurse Kathe Olmstead prepares a shot that is part of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., in Binghamton, N.Y.  The U.S. Food and Drug Administration will hold a meeting to discuss the process of approving COVID-19 vaccines.  (AP Photo/Hans Pennink, File)

US regulators seek advice on thorny issues as vaccines near

Oct. 22, 2020 8:41 PM EDT

WASHINGTON (AP) — Scientific advisers told U.S. regulators Thursday they’re concerned that allowing emergency use of a COVID-19 vaccine could damage confidence in the shots and make it harder to ever find out how well they really work. The Food and Drug Administration may have to decide by year's...

In this image taken from a live-streamed video from the California Governor's Office, California Gov. Gavin Newsom talks during a news conference on Monday, Oct. 19, 2020, in Sacramento, Calif. Newsom said California won't allow any distribution of new coronavirus vaccines in the nation's most populous state until it is reviewed by the state's own panel of experts. (California Governor's Office via AP)

California won't allow virus vaccines without state approval

Oct. 19, 2020 9:16 PM EDT

SACRAMENTO, Calif. (AP) — California won't allow any distribution of coronavirus vaccines in the nation’s most populous state until it is reviewed by the state’s own panel of experts, Gov. Gavin Newsom said Monday. Vaccinations for the pandemic “will move at the speed of trust,”...

FILE - In this July 17, 2020 file photo, a senior citizen holds the hand of a care coordinator at a Health facility in Miami.  Federal health officials on Friday unveiled a plan to get approved coronavirus vaccines to nursing home residents free of cost, with the aid of two national pharmacy chains.
No vaccine has yet been approved by the Food and Drug Administration, and the distribution program is contingent on that happening first. (AP Photo/Wilfredo Lee)

Feds planning now to get coronavirus shots to nursing homes

Oct. 16, 2020 5:28 PM EDT

WASHINGTON (AP) — Federal health officials on Friday unveiled a plan to get yet-to-be-approved coronavirus vaccines to nursing home residents free of charge, enlisting two national pharmacy chains to help. Such a vaccine is not yet available. The distribution program is contingent on the Food and Drug...

FILE - This Thursday, Nov. 2, 2017 photo shows tablets of ibuprofen in New York. On Thursday, Oct. 15, 2020, the Food and Drug Administration said that pregnant women should avoid a group of common pain relievers including Advil and Aleve for the last four months of pregnancy, expanding the warning from three months. (AP Photo/Patrick Sison)

FDA extends pregnancy warning for common pain relievers

Oct. 15, 2020 6:03 PM EDT

WASHINGTON (AP) — Pregnant women should avoid a group of common pain relievers including Advil and Aleve for the last four months of pregnancy, federal health officials said Thursday, expanding the warning from three months. The Food and Drug Administration said the fever-and-pain-reducing drugs can cause...

This image provided by Regeneron on Wednesday, Oct. 14, 2020, shows a vial of the company's Inmazeb medication. On Wednesday, the U.S. Food and Drug Administration said it has approved the drug for treating Ebola in both adults and children. (Regeneron via AP)

US regulators approve 1st treatment for Ebola virus

Oct. 14, 2020 8:44 PM EDT

U.S. regulators Wednesday approved the first drug for the treatment of Ebola. The Food and Drug Administration OK'd the drug developed by Regeneron Pharmaceuticals for treating adults and children with the Zaire Ebola virus strain, the most deadly of six known types. It typically kills 60% to 90% of patients. ...

FILE - In this May 4, 2020 photo provided by the University of Maryland School of Medicine, the first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection. On top of rigorous final testing in tens of thousands of people, any COVID-19 vaccines cleared for widespread use will get additional safety evaluation as they're rolled out. (University of Maryland School of Medicine via AP)

Extra safety scrutiny planned as virus vaccine worries grow

Oct. 14, 2020 11:09 AM EDT

Facing public skepticism about rushed COVID-19 vaccines, U.S. health officials are planning extra scrutiny of the first people vaccinated when shots become available — an added safety layer experts call vital. A new poll suggests those vaccine fears are growing. With this week's pause of a second major...

A medical staff takes a swab from a woman as residents line up for the COVID-19 test near the residential area in Qingdao in east China's Shandong province on Monday, Oct. 12, 2020. Authorities in the eastern Chinese port city of Qingdao said Tuesday that they have completed coronavirus tests on more than 3 million people following the country's first reported local outbreak of the virus in nearly two months. (Chinatopix ia AP)

The Latest: 3 million tested for coronavirus in Chinese city

Oct. 13, 2020 12:00 AM EDT

BEIJING -- Authorities in the eastern Chinese port city of Qingdao say they have completed coronavirus tests on more than 3 million people following the country’s first reported local outbreak of the virus in nearly two months. The city’s health department said Tuesday that no new positive cases had...

A group protests the ongoing outbreak of coronavirus in the White House, Thursday, Oct. 8, 2020, outside the White House in Washington. (AP Photo/Jacquelyn Martin)

Trump says he's ready for rallies; doctor says therapy done

Oct. 8, 2020 10:24 PM EDT

WASHINGTON (AP) — President Donald Trump insisted Thursday that he is ready to resume campaign rallies and feels “perfect” one week after his diagnosis with the coronavirus that has killed more than 210,000 Americans, as his doctor said the president had ”completed his course of...