Product approvals

President Donald Trump talks about a plan to ban most flavored e-cigarettes, in the Oval Office of the White House, Wednesday, Sept. 11, 2019, in Washington. From left, acting FDA Commissioner Ned Sharpless, first lady Melania Trump, Trump, and Secretary of Health and Human Services Alex Azar. (AP Photo/Evan Vucci)
September 11, 2019 - 4:34 pm
WASHINGTON (AP) — The federal government will act to ban thousands of flavors used in e-cigarettes, President Donald Trump said Wednesday, responding to a recent surge in underage vaping that has alarmed parents, politicians and health authorities nationwide. The surprise White House announcement...
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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)
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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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)
August 29, 2019 - 11:29 am
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 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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August 14, 2019 - 2:14 pm
TRENTON, N.J. (AP) — U.S. regulators have 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 developed by a nonprofit group, the TB Alliance, which was formed to come up with...
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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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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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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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