Drug approvals

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)
Associated Press
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,...
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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...
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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...
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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...
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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 - 4:15 pm
TRENTON, N.J. (AP) — U.S. regulatorson Friday approveda 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...
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This undated photo provided by Amarin in November 2018 shows a capsule of the purified, prescription fish oil Vascepa. On Friday, Dec. 13, 2019, U.S. regulators approved expanded use of the medication for preventing serious heart complications in high-risk patients already taking cholesterol-lowering pills. (Amarin via AP)
December 13, 2019 - 5:53 pm
TRENTON, N.J. (AP) — U.S. regulators on Friday approved expanded use of a fish oil-based drug for preventing serious heart complications in high-risk patients already taking cholesterol-lowering pills. Vascepa was approved years ago for people with sky-high triglycerides, a type of fat in blood...
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December 05, 2019 - 12:08 pm
SAN DIEGO (AP) — A company that claims to have the first drug to slow mental decline from Alzheimer's disease made its case to scientists Thursday, disclosing more results that may help explain why one study of the experimental medicine succeeded and another failed. Excitement and skepticism have...
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This undated photo provided by Acadia Pharmaceuticals Inc. shows a bottle of Nuplazid, a drug that was tested for treating psychosis related to dementia. If regulators agree, the drug could become the first treatment specifically for dementia-related psychosis and the first new medicine for Alzheimer's in nearly two decades. Results from a study on the drug were disclosed Wednesday, Dec. 4, 2019, at an Alzheimer's conference in San Diego. (Acadia Pharmaceuticals Inc. via AP)
December 04, 2019 - 8:53 pm
SAN DIEGO (AP) — A drug that curbs delusions in Parkinson's patients did the same for people with Alzheimer's disease and other forms of dementia in a study that was stopped early because the benefit seemed clear. If regulators agree, the drug could become the first treatment specifically for...
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This undated image provided by Novartis shows bottles of Novartis’s Adakveo. U.S. regulators have approved the new sickle cell disease medicine that can prevent extremely painful, dangerous “crises” in which misshapen blood cells clump together, reducing blood and oxygen flow. (Novartis via AP)
November 15, 2019 - 4:35 pm
U.S. regulators on Friday approved a new medicine that can help reduce extremely painful sickle cell disease flare-ups. The Food and Drug Administration approved Novartis AG’s Adakveo for patients 16 and older. The monthly infusion, which halves occurrences of sickle cell pain episodes, will carry...
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August 14, 2019 - 2:14 pm
TRENTON, N.J. (AP) — U.S. regulators have approved a new tuberculosis medicine that shortens and improves treatment for the hardest-to-treat cases, a worsening problem in many poor countries. It's the first TB drug developed by a nonprofit group, the TB Alliance, which was formed to come up with...
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