Drug approvals

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 - 6:24 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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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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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 - 5:51 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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This photo provided by Janssen Global Services shows Spravato nasal spray. Spravato, a mind-altering medication related to the club drug Special K, won U.S. approval Tuesday, March 5, 2019, for patients with hard-to-treat depression, the first in a series of long-overlooked substances being reconsidered for severe forms of mental illness. (Janssen Global Services via AP)
March 06, 2019 - 3:07 am
WASHINGTON (AP) — A mind-altering medication related to the club drug Special K won U.S. approval Tuesday for patients with hard-to-treat depression, the first in a series of long-overlooked substances being reconsidered for severe forms of mental illness. The nasal spray from Johnson & Johnson...
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FILE - In this Oct. 17, 2018, file photo a depiction of a cannabis bud drops from the ceiling at Leafly's countdown party in Toronto as midnight passes and marks the first day of the legalization of cannabis across Canada. The last year was a 12-month champagne toast for the legal marijuana industry as the global market exploded and cannabis pushed its way further into the financial and cultural mainstream. Canada ushered in broad legalization, U.S. drug regulators approved the first cannabis-based drug and investors pumped in billions of dollars. (Chris Young/The Canadian Press via AP, File)
December 27, 2018 - 3:44 pm
PORTLAND, Ore. (AP) — The last year was a 12-month champagne toast for the legal marijuana industry as the global market exploded and cannabis pushed its way further into the financial and cultural mainstream. Liberal California became the largest legal U.S. marketplace, conservative Utah and...
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FILE - In this Jan. 18, 2017 photo marijuana is displayed for sale at a shop in Juneau, Alaska. Alaska regulators approved rules for onsite consumption of marijuana at specially designated shops on Thursday, Dec. 20, 2018, a significant step for the cannabis industry after years of debate. (AP Photo/Mark Thiessen, File)
December 20, 2018 - 7:27 pm
JUNEAU, Alaska (AP) — Alaska regulators on Thursday approved rules for onsite consumption of marijuana at specially designated shops, a significant step for the cannabis industry in the state after years of debate. The 3-2 vote by the Marijuana Control Board does not mean people can light up at...
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This undated image provided by AcelRx Pharmaceuticals shows the dispenser and a tablet for the company's medication Dsuvia. On Friday, Nov. 2. 2018, U.S. regulators announced the approval of the fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals. (Craig Sherod Photography/AcelRx Pharmaceuticals via AP)
November 02, 2018 - 3:24 pm
TRENTON, N.J. (AP) — U.S. regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals. The decision by the Food and Drug Administration on Friday came over objections from critics who fear the pill will be abused. In a lengthy...
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This undated product image provided by Genentech shows a box for Xofluza, a pill for shortening the duration and easing symptoms of the flu. U.S. health regulators have approved the first new type of flu drug in two decades. The approval on Wednesday, Oct. 24, 2018, of Roche’s Xofluza comes ahead of this winter’s flu season. (Genentech via AP)
October 24, 2018 - 2:09 pm
TRENTON, N.J. (AP) — U.S. health regulators have approved the first new type of flu drug in two decades. Wednesday's approval of Xofluza for people age 12 and older comes ahead of the brunt of this winter's flu season. Xofluza is a pill that can reduce severity and shorten duration of flu symptoms...
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