Product approvals

May 17, 2018 - 8:38 am
TOKYO (AP) — Japanese electronics company Toshiba Corp. says the sale of its computer memory chip business to a consortium led by Bain Capital Private Equity has cleared all anti-trust regulatory approval, including a final one it was awaiting from China. Toshiba said Thursday that means the deal,...
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FILE - In this Friday, July 8, 2016 file photo, a prescription is filled at a pharmacy in Sacramento, Calif. On Friday, May 11 2018, Trump is scheduled to give his first speech on how his administration will seek to lower drug prices. (AP Photo/Rich Pedroncelli, File)
May 10, 2018 - 8:07 pm
WASHINGTON (AP) — Before taking office, President Donald Trump railed against the pharmaceutical industry and accused it of "getting away with murder." The populist rhetoric appears to be giving way to a more nuanced strategy focused on making the pharmaceutical market more open and competitive,...
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FILE - This May 23, 2017 file photo shows GW Pharmaceuticals’ Epidiolex, a medicine made from the marijuana plant but without THC. On Thursday, April 19, 2018, a panel of Food and Drug Administration health advisers recommended approval of the drug, moving the closely watched medication closer to the U.S. market. (AP Photo/Kathy Young, File)
April 19, 2018 - 1:05 pm
WASHINGTON (AP) — A medicine made from the marijuana plant moved one step closer to U.S. approval Thursday after federal health advisers endorsed it for the treatment of severe seizures in children with epilepsy. If the Food and Drug Administration follows the group's recommendation, GW...
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April 17, 2018 - 11:46 am
WASHINGTON (AP) — U.S. health officials on Tuesday proposed steps to improve the government's system for overseeing medical devices, which has been criticized for years for failing to catch problems with risky implants and medical instruments. The plan from the Food and Drug Administration includes...
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FILE - In this Monday, Nov. 6, 2017 file photo, Brian Madeux sits with his girlfriend Marcie Humphrey while waiting to receive the first human gene editing therapy at the UCSF Benioff Children's Hospital in Oakland, Calif. Madeux, who has Hunter syndrome, received the treatment on Monday, Nov. 13. Gene therapy aims to treat the root cause of a problem by deleting, adding or altering DNA, rather than just treating symptoms that result from the genetic flaw. (AP Photo/Eric Risberg)
December 28, 2017 - 10:23 am
After decades of hope and high promise, this was the year scientists really showed they could doctor DNA to successfully treat diseases. Gene therapies to treat cancer and even pull off the biblical-sounding feat of helping the blind to see were approved by U.S. regulators, establishing gene...
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November 30, 2017 - 9:25 pm
WASHINGTON (AP) — U.S. health officials on Thursday approved the first injectable form of the leading medication to treat patients recovering from addiction to heroin, prescription painkillers and other opioids. The Food and Drug Administration approved once-a-month Sublocade for adults with opioid...
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FILE - This Oct. 14, 2015, file photo, shows the U.S. Food & Drug Administration campus in Silver Spring, Md. On Monday, Nov. 13, 2017, the FDA approved the first drug in the United States with a digital ingestion tracking system, in an unprecedented move to ensure that patients with mental illness take the medicine prescribed for them. The drug Abilify MyCite was developed by Otsuka Pharmaceutical Co., Ltd. (AP Photo/Andrew Harnik, File)
November 14, 2017 - 12:43 pm
WASHINGTON (AP) — U.S. regulators have approved the first drug with a sensor that alerts doctors when the medication has been taken, offering a new way of monitoring patients but also raising privacy concerns. The digital pill approved Monday combines two existing products: the former blockbuster...
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FILE - In this Thursday, Feb. 28, 2013, file photo, a Merck scientist conducts research in West Point, Pa. On Wednesday, Nov. 8, 2017, the Food and Drug Administration approved sales of Merck and Co.'s Prevymix, the first drug to prevent life-threatening infections in adults after a bone marrow transplant. (AP Photo/Matt Rourke, File)
November 08, 2017 - 6:23 pm
TRENTON, N.J. (AP) — U.S. regulators have approved the first drug to prevent life-threatening infections in adults after a bone marrow transplant. The Food and Drug Administration on Wednesday approved sales of Merck and Co.'s Prevymix (PREH'-vih-miss) to prevent infections with cytomegalovirus (sy...
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FILE - In this May 2016 file photo provided by Kite Pharma, cell therapy specialists at the company's manufacturing facility in El Segundo, Calif., prepare blood cells from a patient to be engineered in the lab to fight cancer. On Wednesday, Oct. 18, 2017, the Food and Drug Administration approved sales of the therapy Yescarta, developed by Kite Pharma. It is the second gene therapy for U.S. patients _ the first one for adults _ a custom-made, one-time treatment for certain common types of the blood cancer lymphoma. (Kite Pharma via AP, File)
October 18, 2017 - 8:27 pm
TRENTON, N.J. (AP) — U.S. regulators have approved a second gene therapy for a blood cancer, a one-time, custom-made treatment for aggressive lymphoma in adults. The Food and Drug Administration allowed sales of the treatment from Kite Pharma on Wednesday. It uses the same technology, called CAR-T...
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Dr. Barry Byrne listens to testimony concerning the approval of a potentially breakthrough drug for a form of blindness during a meeting of the The Cellular, Tissue and Gene Therapies advisory committee, Thursday, Oct. 12. 2017, at the FDA in Silver Spring, Md. (AP Photo/Nick Wass)
October 12, 2017 - 7:55 pm
SILVER SPRING, Md. (AP) — A potentially groundbreaking treatment for a rare form of blindness moved one step closer to U.S. approval Thursday, as federal health advisers endorsed the experimental gene therapy for patients with an inherited condition that gradually destroys eyesight. The panel...
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