Drug approvals

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)
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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 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)
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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)
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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...
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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)
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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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This image provided by Sarepta Therapeutics in December 2019 shows a box and vial of their drug Vyondys 53. On Thursday, Dec. 12, 2019, U.S. health regulators said they approved this second drug for a debilitating form of muscular dystrophy, a surprise decision after the medication was rejected for safety concerns just four months earlier. (Sarepta Therapeutics via AP)
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December 13, 2019 - 4:19 pm
WASHINGTON (AP) — U.S. health regulators approved a second drug for a debilitating form of muscular dystrophy, a surprise decision after the medication was rejected for safety concerns just four months ago. The ruling marks the second time the Food and Drug Administration has granted preliminary...
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In this Nov. 22, 2019, photo, Charles Flagg, who is stricken with Alzheimer's disease, receives the contents of an intravenous bag while participating in a study on the drug Aducanumab at Butler Hospital in Providence, R.I. New results were released on the experimental medicine whose maker claims it can slow the decline of Alzheimer's disease, the most common form of dementia. (AP Photo/Charles Krupa)
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December 05, 2019 - 3:20 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 but left them sharply divided over whether there’s enough evidence of effectiveness for the medicine to warrant federal approval. Excitement and...
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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)
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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)
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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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FILE - In this Aug. 14, 2018 file photo, Dr. William Burke goes over a PET brain scan at Banner Alzheimers Institute in Phoenix. The drug company Biogen Inc. says it will seek federal approval for a medicine to treat early Alzheimer's disease, a landmark step toward finding a treatment that can alter the course of the most common form of dementia. The announcement Tuesday, Oct. 22, 2019, is a surprise because the company earlier this year stopped two studies of the drug, called aducanumab, after partial results suggested it was not working. (AP Photo/Matt York, File)
1010 WINS Newsroom
October 22, 2019 - 6:44 pm
Biogen Inc. said Tuesday it will seek federal approval for a medicine to treat early Alzheimer's disease, a landmark step toward finding a treatment that can alter the course of the most common form of dementia. The announcement was a surprise because the drug company earlier this year stopped two...
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This undated photo provided by the TB Alliance in August 2019 shows the drug pretomanid. On Wednesday, Aug. 14, 2019, the U.S. Food and Drug Administration approved pretomanid, the first tuberculosis drug developed by a nonprofit group. The TB Alliance was formed to come up with better treatments for the pulmonary disease. (TB Alliance via AP)
August 14, 2019 - 4:51 pm
TRENTON, N.J. (AP) — U.S. regulators Wednesday 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 from a nonprofit group, the TB Alliance. Formed to come up with better...
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