Product approvals

FILE - In this May 14, 2020, file pool photo Rick Bright, former director of the Biomedical Advanced Research and Development Authority, testifies before a House Energy and Commerce Subcommittee on Health hearing to discuss protecting scientific integrity in response to the coronavirus outbreak on Capitol Hill in Washington. Bright, a government whistleblower ousted from a leading role in battling COVID-19, alleged Thursday, June 25, that the Trump administration has intensified its campaign to punish him for revealing shortcomings in the U.S. response. (Shawn Thew/Pool via AP, File)
June 25, 2020 - 8:53 pm
WASHINGTON (AP) — A government whistleblower ousted from a leading role in battling COVID-19 alleged Thursday that the Trump administration has intensified its campaign to punish him for revealing shortcomings in the U.S. response. Dr. Rick Bright, former director of the Biomedical Advanced...
Read More
FILE - This Oct. 14, 2015 file photo shows the Food and Drug Administration campus in Silver Spring, Md. On Wednesday, June 17, 2020, the FDA said it has sent warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests. The companies targeted by FDA include: Medakit Ltd. of Hong Kong, Antibodiescheck.com of the United Arab Emirates and Sonrisa Family Dental D.B.A. My COVID19 Club of Chicago. (AP Photo/Andrew Harnik, File)
June 18, 2020 - 9:53 am
WASHINGTON (AP) — A company targeted by the Food and Drug Administration for selling unauthorized coronavirus antibody tests says it has responded to regulators' concerns, though it has no business operations in the U.S. The Food and Drug Administration announced Wednesday it had sent warning...
Read More
FILE - In this Aug. 2, 2018, file photo, the U.S. Food and Drug Administration (FDA) building is visible behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md. The U.S. Food and Drug Administration has for the first time approved a video game for treating attention deficit hyperactivity disorder in children. The FDA said Monday, June 15, 2020, the game built by Boston-based Akili Interactive Labs can improve attention function. (AP Photo/Jacquelyn Martin, File)
June 15, 2020 - 7:17 pm
BOSTON (AP) — The U.S. Food and Drug Administration has for the first time approved a video game for treating attention deficit hyperactivity disorder in children. The FDA said Monday the game built by Boston-based Akili Interactive Labs can improve attention function. The game, called EndeavorRx,...
Read More
This May 2020 photo shows Phexxi, a contraceptive made by San Diego-based Evofem Bioscience. The Food and Drug Administration on Friday, May 22, 2020 approved the new contraceptive. (Christine Blackburne via AP)
May 22, 2020 - 2:53 pm
U.S. regulators on Friday approved a birth control gel that works in a new way to prevent pregnancy. Phexxi comes in an applicator that women insert before sex. The gel made by San Diego-based Evofem Biosciences contains lactic acid, citric acid and potassium bitartrate, all of which are common...
Read More
FILE - In this June 3, 2019 file photo, Dr. Yasser Awaad, right, leaves court in Detroit. Awaad, a Detroit-area doctor accused of misdiagnosing epilepsy in more than 200 children surrendered his medical license and agreed to pay a $5,000 penalty under a settlement accepted Wednesday, May 20, 2020 by state regulators. (AP Photo/Edward J. White, File)
May 20, 2020 - 12:04 pm
DETROIT (AP) — A Detroit-area doctor accused of misdiagnosing epilepsy in more than 200 children surrendered his medical license and agreed to pay a $5,000 penalty under a settlement accepted Wednesday by state regulators. “A great day for patients that was long overdue,” said attorney Brian McKeen...
Read More
FILE - In this Thursday, Jan. 2, 2020 file photo, vaping devices are displayed at a store in New York. On Thursday, April 23, 2020, the U.S. Food and Drug Administration said that a federal court accepted its request to push back the May 12 deadline to submit vaping product applications to Sept. 9. The agency said the COVID-19 pandemic has delayed preparations to meet the deadline for both companies and FDA staff. (AP Photo/Mary Altaffer)
April 23, 2020 - 3:28 pm
WASHINGTON (AP) — Electronic cigarette companies will have four additional months to submit their products for government review because of delays tied to the coronavirus outbreak. The Food and Drug Administration said Thursday that a federal court accepted its request to push back the May 12...
Read More
This photo provided by Seattle Genetics Inc., shows the breast cancer drug Tukysa, developed by Seattle Genetics. U.S. regulators on Thursday, April 14, 2020, approved the new drug for an aggressive type of breast cancer that’s spread in the body, including into the brain, where it’s especially tough to treat. (Seattle Genetics via AP)
April 17, 2020 - 2:16 pm
U.S. regulators on Friday approved a new drug for an aggressive type of breast cancer that’s spread in the body — including into the brain, where it’s especially tough to treat. The Food and Drug Administration said Tukysa, a twice-daily pill developed by Seattle Genetics, is for people with what's...
Read More
In this April 3, 2020, photo, blue preservation solution is shown at Spectrum DNA in Draper, Utah. The company has developed a test kit to detect the coronavirus in patients' saliva. At least two Utah companies have developed tests and gotten emergency authorization from the U.S. Food and Drug Administration: molecular diagnostics company Co-Diagnostics and ancestry-testing kit maker Spectrum DNA. (AP Photo/Rick Bowmer)
April 13, 2020 - 4:52 pm
WASHINGTON (AP) — Rutgers University researchers have received U.S. government clearance for the first saliva test to help diagnose COVID-19, a new approach that could help expand testing options and reduce risks of infection for health care workers. The Food and Drug Administration authorized the...
Read More
FILE - In this Monday, March 2, 2020 file photo, Gilead Sciences CEO Daniel O'Day speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House in Washington. Gilead, the pharmaceutical giant that makes remdesivir, a promising coronavirus drug, has registered it as a rare disease treatment with U.S. regulators on Monday, March 23, 2020, a status that can potentially be worth millions in tax breaks and competition-free sales. (AP Photo/Andrew Harnik)
March 24, 2020 - 9:11 pm
WASHINGTON (AP) — The pharmaceutical giant that makes a promising coronavirus drug has registered it as a rare disease treatment with U.S. regulators, a status that can potentially be worth millions in tax breaks and competition-free sales. What that specialty status will actually mean for the...
Read More
This undated photo provided by Esperion Inc. shows the cholesterol-lowering drug Nexletol made by Esperion Therapeutics Inc. The Food and Drug Administration on Friday, Feb. 21, 2020 approved Esperion Therapeutics Inc.’s Nexletol for people genetically predisposed to have sky-high cholesterol and others who have heart disease and need to further lower their bad cholesterol.(Esperion Inc. via AP)
February 21, 2020 - 4:41 pm
TRENTON, N.J. (AP) — U.S. regulators on Friday approved a new type of cholesterol-lowering drug aimed at millions of people who can't tolerate — or don't get enough help from — widely used statin pills like Lipitor and Crestor. The Food and Drug Administration approved Esperion Therapeutics Inc.’s...
Read More

Pages