Product approvals

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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October 09, 2017 - 6:46 am
BEIJING (AP) — China will allow use of some drugs and medical devices based on approval by foreign regulators, the government said Monday, in a move that could help to ease access to its health care market. The step was one of a series announced by Chinese drug regulators to improve access to...
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This April 26, 2017, photo shows the Eli Lilly and Co. corporate headquarters in Indianapolis. On Thursday, Sept. 28, 2017, the Food and Drug Administration approved Eli Lilly's Verzenio, a new medicine for treating adults with a common type of breast cancer that has spread. (AP Photo/Darron Cummings)
September 28, 2017 - 5:27 pm
U.S. regulators have approved a new medicine for treating a common type of breast cancer that has spread to other parts of the body. Eli Lilly's Verzenio (verr-ZEHN'ee-oh) was approved Thursday by the Food and Drug Administration for patients with what's called HR-positive, HER2-negative breast...
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In this July 9, 2015, photo, provided by Novartis Pharmaceuticals Corp., human T cells belonging to cancer patients arrive at Novartis Pharmaceuticals Corp.'s Morris Plains, N.J., facility. The Food and Drug Administration (FDA) approved the first treatment that genetically engineers patients’ own blood cells into an army of leukemia-fighting assassins. Manufacturer Novartis will create those turbocharged cells in this facility and ship them back to hospitals to infuse into patients. (Brent Stirton/Novartis Pharmaceuticals Corp. via AP)
August 30, 2017 - 5:26 pm
WASHINGTON (AP) — Opening a new era in cancer care, U.S. health officials on Wednesday approved a breakthrough treatment that genetically engineers patients' own blood cells into an army of assassins to seek and destroy childhood leukemia. The Food and Drug Administration called the approval...
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This photo provided by the Children’s Hospital of Philadelphia, taken in May 2017, shows Emily Whitehead five years after she became the first pediatric patient in the world to receive an experimental therapy at the hospital that has put her leukemia into long-term remission. Opening a new era in cancer care, the Food and Drug Administration (FDA) approved the first treatment that genetically engineers patients' own blood cells into an army of assassins to seek and destroy childhood leukemia. (Children’s Hospital of Philadelphia via AP)
August 30, 2017 - 12:44 pm
WASHINGTON (AP) — Opening a new era in cancer care, the Food and Drug Administration on Wednesday approved the first treatment that genetically engineers patients' own blood cells into an army of assassins to seek and destroy childhood leukemia. The CAR-T cell treatment developed by Novartis...
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August 30, 2017 - 11:27 am
WASHINGTON (AP) — Opening a new era in cancer care, the Food and Drug Administration on Wednesday approved the first treatment that genetically engineers patients' own blood cells into an army of assassins to seek and destroy childhood leukemia. The CAR-T cell treatment developed by Novartis and...
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