Drug approvals

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)
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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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This photo provided by Novartis shows their gene therapy medicine Zolgensma. U.S. regulators want to know why Novartis didn't disclose a problem with testing data until after they approved the Swiss drugmaker’s $2.125 million gene therapy. On Tuesday, Aug. 6, 2019, the Food and Drug Administration said the questionable data involves testing of the therapy, Zologensma, on animals, not on patients. (Novartis via AP)
August 06, 2019 - 6:51 pm
TRENTON, N.J. (AP) — U.S. regulators want to know why Novartis didn't disclose a problem with testing data until after the Swiss drugmaker's $2.1 million gene therapy was approved. The Food and Drug Administration said Tuesday the manipulated data involved testing in animals, not patients, and it's...
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FILE - This Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md. The FDA has approved the first generic copies of a popular, pricey pill for nerve pain. The agency on Monday, July 22, 2019, said it approved nine generic versions of Pfizer Inc.’s Lyrica. (AP Photo/Jacquelyn Martin, File)
July 22, 2019 - 3:15 pm
TRENTON, N.J. (AP) — The U.S. Food and Drug Administration has approved the first generic copies of a popular, pricey pill for nerve pain. The agency on Monday said it approved nine generic versions of Pfizer Inc.'s Lyrica. It is also used for seizures and fibromyalgia, a condition that causes...
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This image provided by Amag Pharmaceuticals in June 2019 shows packaging for their drug Vyleesi. The medication OK'd Friday, June 21, 2019 by the U.S. Food and Drug Administration is only the second approved to increase sexual desire in a women, a market drugmakers have been trying to cultivate since the blockbuster success of Viagra for men in the late 1990s. (Amag Pharmaceuticals via AP)
June 21, 2019 - 6:20 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 - 2:35 pm
U.S. regulators have approved the most expensive medicine ever, for a disorder that destroys a baby's muscle control and kills nearly all of those with the most common variant of the disease within a couple years. The treatment is priced at $2.125 million. Out-of-pocket costs for patients will vary...
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FILE - In this April 16, 2019, file photo, a woman exhales a puff of vapor from a Juul pen in Vancouver, Wash. Under intense scrutiny amid a wave of underage vaping, Juul is pushing into television with a multimillion-dollar campaign rebranding itself as a stop-smoking aid for adults trying to kick cigarettes. (AP Photo/Craig Mitchelldyer, File)
May 09, 2019 - 4:24 pm
WASHINGTON (AP) — The young models and the candy-colored graphics that helped propel Juul to the top of the e-cigarette market are gone. In their place are people like Carolyn, a 54-year-old former smoker featured in new TV commercials touting Juul as an alternative for middle-age smokers. "I don't...
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March 19, 2019 - 7:06 pm
TRENTON, N.J. (AP) — The U.S. Food and Drug Administration has approved the first drug specifically developed for severe depression after childbirth. The agency on Tuesday approved Sage Therapeutics' Zulresso, an IV drug given over 2 ½ days. Sage said Zulresso will cost $34,000 without insurance,...
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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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