Product approvals

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)
1010 WINS Newsroom
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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FILE - In this Feb. 20, 2014, file photo, a patron exhales vapor from an e-cigarette at a store in New York. Only two years ago e-cigarettes were viewed as holding great potential for public health: offering a way to wean smokers off traditional cigarettes. But now Juul and other vaping companies face an escalating backlash that threatens to sweep their products off the market. (AP Photo/Frank Franklin II, File)
1010 WINS Newsroom
October 05, 2019 - 11:36 am
WASHINGTON (AP) — Only two years ago, electronic cigarettes were viewed as a small industry with big potential to improve public health by offering a path to steer millions of smokers away from deadly cigarettes. That promise led U.S. regulators to take a hands-off approach to e-cigarette makers,...
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FILE - In this Thursday, Nov. 10, 2016 file photo, test cigarettes burn in a smoking machine at the Centers for Disease Control and Prevention in Atlanta. A decade after President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act into law in 2009, health advocates say the Food and Drug Administration has yet to put in place the most sweeping changes envisioned by Congress. (AP Photo/Branden Camp)
1010 WINS Newsroom
August 29, 2019 - 1:12 pm
WASHINGTON (AP) — It seemed like a new era in the half-century battle against the deadly toll of tobacco: U.S. health officials for the first time would begin regulating cigarettes, chew and other products responsible for a half-million American deaths annually. "The decades-long effort to protect...
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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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In this June 13, 2019, photo released by Xinhua News Agency, guests, from left, Yi Huiman, chairman of China Securities Regulatory Commission, Liu He, vice premier, Li Qiang, top party official of Shanghai, and Ying Yong, Shanghai's mayor, celebrate the launch of the SSE STAR Market, previously referred to as the Shanghai science and technology innovation board in Shanghai. Trading is expected to start Monday, July 22, 2019 on the Chinese stock market for high-tech companies that play a key role in official development plans that are straining relations with Washington. (Fang Zhe/Xinhua via AP)
July 20, 2019 - 8:45 pm
BEIJING (AP) — Trading starts Monday on a Chinese stock market for high-tech companies that play a key role in official development plans that are straining relations with Washington. Regulators have approved 25 companies in information technology and other fields seen by communist leaders as a...
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In this June 13, 2019, photo released by Xinhua News Agency, guests, from left, Yi Huiman, chairman of China Securities Regulatory Commission, Liu He, vice premier, Li Qiang, top party official of Shanghai, and Ying Yong, Shanghai's mayor, celebrate the launch of the SSE STAR Market, previously referred to as the Shanghai science and technology innovation board in Shanghai. Trading is expected to start Monday, July 22, 2019 on the Chinese stock market for high-tech companies that play a key role in official development plans that are straining relations with Washington. (Fang Zhe/Xinhua via AP)
July 18, 2019 - 1:25 am
BEIJING (AP) — Trading starts Monday on a Chinese stock market for high-tech companies that play a key role in official development plans that are straining relations with Washington. Regulators have approved 25 companies in information technology and other fields seen by communist leaders as a...
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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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