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"FDA Approval"

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 Approvals in 2017

By: Jason Marcewicz  |  Content and Communications Specialist | Advanced Medical Strategies The FDA approved 46 new molecular entities (NMEs) in 2017, the most in over two decades. (Just 22 NMEs were approved in all of 2016; the average approval rate for the past decade is about 30 per year.) This list of so-called novel... Read More »

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By: Jason Marcewicz  |  Content and Communications Specialist | Advanced Medical Strategies The FDA approved 46 new molecular entities (NMEs) in 2017, the most in over two decades. (Just 22 NMEs were approved in all of 2016; the average approval rate for the past decade is about 30 per year.) This list of so-called novel… 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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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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FDA clears first neonatal magnetic resonance imaging device

Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). “Although we can use traditional MRI scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges,” said Vasum... Read More »

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Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). “Although we can use traditional MRI scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges,” said Vasum… Read More »

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The FDA Approved the First New Sickle Cell Drug in 20 Years…But It’s Not a Cure

News that the Food and Drug Administration (FDA) approved the first new drug to treat sickle cell in nearly 20 years last Friday understandably drew cheers from patients and advocates who have stood by with bated breath for a breakthrough. But as laudable as the milestone may be, the treatment’s limited reach underscores just how... Read More »

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News that the Food and Drug Administration (FDA) approved the first new drug to treat sickle cell in nearly 20 years last Friday understandably drew cheers from patients and advocates who have stood by with bated breath for a breakthrough. But as laudable as the milestone may be, the treatment’s limited reach underscores just how… Read More »

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FDA approves first new drug for ALS treatment in 22 years

The US Food and Drug Administration has approved the first new drug for the treatment of amyotrophic lateral sclerosis, or ALS, in more than two decades. The FDA announced Friday that Radicava, also known as edaravone, has been approved for use in the United States. The only other drug specifically for the treatment of ALS... Read More »

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The US Food and Drug Administration has approved the first new drug for the treatment of amyotrophic lateral sclerosis, or ALS, in more than two decades. The FDA announced Friday that Radicava, also known as edaravone, has been approved for use in the United States. The only other drug specifically for the treatment of ALS… Read More »

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Approving a Problematic Muscular Dystrophy Drug Implications for FDA Policy

In September 2016, the US Food and Drug Administration (FDA) approved eteplirsen (Exondys 51), a new drug for Duchenne muscular dystrophy (DMD), overruling the recommendations of both its scientific staff and its external advisory committee. Duchenne muscular dystrophy is a progressive and usually fatal X-linked genetic disease caused by mutations in a gene that produces... Read More »

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In September 2016, the US Food and Drug Administration (FDA) approved eteplirsen (Exondys 51), a new drug for Duchenne muscular dystrophy (DMD), overruling the recommendations of both its scientific staff and its external advisory committee. Duchenne muscular dystrophy is a progressive and usually fatal X-linked genetic disease caused by mutations in a gene that produces… Read More »

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Insulin

In a previous AMS blog posting we reported on the FDA’s approval for an automated basal insulin delivery device. The Medtronic’s MiniMed 670G hybrid closed looped system eliminates the manual process of patients’ continuously checking their baseline glucose levels and administering insulin through needles or pumps. For the 1.25 million American children and adults with... Read More »

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In a previous AMS blog posting we reported on the FDA’s approval for an automated basal insulin delivery device. The Medtronic’s MiniMed 670G hybrid closed looped system eliminates the manual process of patients’ continuously checking their baseline glucose levels and administering insulin through needles or pumps. For the 1.25 million American children and adults with… Read More »

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FDA approves first automated insulin delivery device for type 1 diabetes

The U.S. Food and Drug Administration today approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes. The human pancreas naturally supplies a low, continuous rate of... Read More »

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The U.S. Food and Drug Administration today approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes. The human pancreas naturally supplies a low, continuous rate of… Read More »

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