Product approvals

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)
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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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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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 - 6:24 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 - In this Tuesday, July 16, 2019, file photo, Health and Human Services Secretary Alex Azar pauses while speaking during a Cabinet meeting at the White House, in Washington. Azar says he and President Donald Trump are working on a plan to allow Americans to import lower-priced prescription drugs from Canada. (AP Photo/Alex Brandon, File)
July 31, 2019 - 10:35 am
WASHINGTON (AP) — The Trump administration said Wednesday it will set up a system allowing Americans to legally and safely import lower-cost prescription drugs from Canada for the first time, reversing years of opposition from federal health authorities amid a public outcry over high prices for...
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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 - 1:38 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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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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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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