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Key FDA Actions Anticipated in 2018

The FDA approved a number of new therapies and indications for a variety of conditions this past year (read our 2017 recap here). With 2017 behind us, we’re looking ahead at the next year for what’s on the horizon in pharmacy. These are some of the upcoming drugs slated for review by the FDA in... Read More »

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The FDA approved a number of new therapies and indications for a variety of conditions this past year (read our 2017 recap here). With 2017 behind us, we’re looking ahead at the next year for what’s on the horizon in pharmacy. These are some of the upcoming drugs slated for review by the FDA in… Read More »

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2017 drug approvals: Records, milestones, and controversies

In his first year as FDA Commissioner, Scott Gottlieb has chaperoned the agency through a blockbuster 2017 with 46 novel drug approvals to date. The final tally is the highest seen this century, surpassing the previous record holder 2015, which clocked in at 45. Both were more than double 2016’s sad tally of 22 new molecular... Read More »

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In his first year as FDA Commissioner, Scott Gottlieb has chaperoned the agency through a blockbuster 2017 with 46 novel drug approvals to date. The final tally is the highest seen this century, surpassing the previous record holder 2015, which clocked in at 45. Both were more than double 2016’s sad tally of 22 new molecular… Read More »

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FDA permits marketing of device to treat diabetic foot ulcers

December 28th, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. “Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The... Read More »

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December 28th, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. “Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The… Read More »

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FDA approves first biosimilar for the treatment of certain breast and stomach cancers

The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or... Read More »

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The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or… Read More »

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FDA approves first-of-a-kind test for cancer gene profiling

U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once, giving a more complete picture of what’s driving a patient’s tumor and aiding efforts to match treatments to those flaws. The U.S. Food and Drug Administration approved Foundation Medicine’s test for patients with advanced or widely spread... Read More »

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U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once, giving a more complete picture of what’s driving a patient’s tumor and aiding efforts to match treatments to those flaws. The U.S. Food and Drug Administration approved Foundation Medicine’s test for patients with advanced or widely spread… Read More »

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The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses. Cataracts are a common eye condition where… Read More »

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Calorie counts on menus are going to be mandatory in 2018

It’s finally happening. After nearly a decade of delays, the Food and Drug Administration is expected to implement an Obama-era policy that will require restaurants and other food outlets with 20 or more locations to post calorie counts beginning May 2018. Any big chain — from grocery stores to movie theaters, amusement parks to vending... Read More »

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It’s finally happening. After nearly a decade of delays, the Food and Drug Administration is expected to implement an Obama-era policy that will require restaurants and other food outlets with 20 or more locations to post calorie counts beginning May 2018. Any big chain — from grocery stores to movie theaters, amusement parks to vending… Read More »

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Pressure mounts to lift FDA restrictions on off-label drugs

When the Food and Drug Administration gives its okay for a new drug to be sold, it specifies the diseases or conditions for which the medicine has been approved. That does not mean doctors can’t prescribe that drug for other ailments. They do. All the time. And it’s perfectly legal. But for decades drugmakers have... Read More »

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When the Food and Drug Administration gives its okay for a new drug to be sold, it specifies the diseases or conditions for which the medicine has been approved. That does not mean doctors can’t prescribe that drug for other ailments. They do. All the time. And it’s perfectly legal. But for decades drugmakers have… Read More »

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Seeing hope: FDA panel considers gene therapy for blindness

A girl saw her mother’s face for the first time. A boy tore through the aisles of Target, marveling at toys he never knew existed. A teen walked onto a stage and watched the stunned expressions of celebrity judges as he wowed “America’s Got Talent.” Caroline, Cole, Christian. All had mere glimmers of vision and... Read More »

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A girl saw her mother’s face for the first time. A boy tore through the aisles of Target, marveling at toys he never knew existed. A teen walked onto a stage and watched the stunned expressions of celebrity judges as he wowed “America’s Got Talent.” Caroline, Cole, Christian. All had mere glimmers of vision and… Read More »

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Flimsy evidence behind many FDA approvals

Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in the Journal of the American Medical Association. The Accelerated Approval pathway makes potentially promising investigational medicines available for use... Read More »

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Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in the Journal of the American Medical Association. The Accelerated Approval pathway makes potentially promising investigational medicines available for use… Read More »

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