Drug approvals

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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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)
December 13, 2019 - 2:28 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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Charles Flagg, who is stricken with Alzheimer's disease, sits for an infusion 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)
December 05, 2019 - 3:43 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)
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 - 3:48 pm
U.S. regulators on Friday approved a new medicine that can prevent some 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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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 - 4:16 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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June 21, 2019 - 6:01 pm
WASHINGTON (AP) — U.S. women will soon have another drug option designed to boost low sex drive: a shot they can give themselves in the thigh or abdomen that raises sexual interest for several hours. The medication OK'd Friday by the Food and Drug Administration is only the second approved to...
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FILE - In this March 26, 2019, file photo, a baggage handler waits for luggage to arrive to sort and deliver to passengers at Dulles International Airport in Dulles, Va. The Transportation Security Administration has changed its cannabis policy to allow passengers to travel with some forms of CBD oil and a drug derived from marijuana that has been approved by the Food and Drug Administration. (AP Photo/Cliff Owen, File)
May 28, 2019 - 7:59 pm
WASHINGTON (AP) — The Transportation Security Administration has changed its cannabis policy to allow passengers to travel with some forms of CBD oil and a drug derived from marijuana that has been approved by the Food and Drug Administration. All forms of marijuana were previously prohibited in...
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This photo provided by Novartis shows Zolgensma. The one-time gene therapy developed by Novartis, Zolgensma, will cost $2.125 million. It treats a rare condition called spinal muscular atrophy, or SMA, which strikes about 400 babies born in the U.S. each year. The therapy, given in a one-hour infusion, was approved for children under age 2 and will be available within two weeks. (Novartis via AP)
May 24, 2019 - 5:15 pm
U.S. regulators have approved the most expensive medicine ever, for a rare disorder that destroys a baby's muscle control and kills nearly all of those with the most common type of the disease within a couple of years. The treatment is priced at $2.125 million. Out-of-pocket costs for patients will...
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FILE - This Oct. 14, 2015 file photo shows the Food & Drug Administration campus in Silver Spring, Md. On Friday, March 8, 2019, the FDA approved Roche’s Tecentriq, the first cancer immunotherapy for treating an aggressive type of breast cancer. (AP Photo/Andrew Harnik, File)
March 08, 2019 - 6:26 pm
The U.S. Food and Drug Administration has approved the first immunotherapy drug for breast cancer. Swiss drugmaker Roche's Tecentriq was OK'd Friday for treating advanced triple-negative breast cancer, which accounts for about 15 percent of cases. It's to be given with chemotherapy, the standard...
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