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Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval

Legacy MEDSearch

Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse ® ) for the subcutaneous delivery of EMPAVELI ® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. “Enable’s purpose is to redefine drug delivery for the benefit of patients. .

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PolarisAR Receives Clearance from the U.S. Food and Drug Administration for Stellar Knee

Legacy MEDSearch

Food and Drug Administration (FDA). These technologies, while delivering important data that can be used to personalize the operation for each patient, require a large footprint in my OR and a significant financial commitment from my institution.

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Cardio Flow, Inc., Announces U.S. Food and Drug Administration (FDA) 510(k) Clearance for its FreedomFlow® Orbital Atherectomy Peripheral Platform

Legacy MEDSearch

Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. CEO of Cardio Flow, stated: “Cardio Flow is committed to providing meaningful solutions that directly address the needs of physicians and their PAD patients through innovative product development.

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Lazurite is Recognized in the 2022 Medical Device Network Excellence Awards & Rankings for its ArthroFree™ System

Legacy MEDSearch

Medical device and technology company Lazurite has received recognition from Medical Device Network Excellence Awards & Rankings, one of the largest, most prestigious, and widely recognized programs in the industry. All Commended companies will be entered into the Medical Device Network Awards at the end of the year. “The

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NIH spending for drugs approved 2010-2019 lower than industry spending, study finds

European Pharmaceutical Review

billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. million publications describing basic or applied research related to 386 of 387 drugs approved 2010-2019 with $8.1 million per approved drug. This was ~10 percent of reported industry spending.

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Avadel Pharmaceuticals launches excessive daytime sleepiness therapy in US

Pharmaceutical Technology

Avadel Pharmaceuticals has introduced LUMRYZ (sodium oxybate) for commercial use in the US to treat cataplexy (excessive daytime sleepiness, or EDS) in adult patients with narcolepsy. The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023.

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Amgen opens its most advanced manufacturing facility to date

European Pharmaceutical Review

The new facility, known as Amgen Ohio, “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,'” stated Robert Bradway, Chairman and Chief Executive Officer at Amgen. ” Amgen Ohio is nearly 300,000 ft 2 in size and will employ 400 full-time staff.