FDA approves Omlyclo (omalizumab-igec), a biosimilar to Xolair (omalizumab). View the prescribing information: https://lnkd.in/enCsQwiV
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The Food and Drug Administration is an agency within the Department of Health and Human Services. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
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https://www.fda.gov/
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US，MD，Silver Spring，20993
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动态
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FDA expands the indication for an epinephrine nasal spray to include children four years of age and older who weigh 15 kg to less than 30 kg. Read the updated prescribing information to learn more: https://lnkd.in/eWx5MZBT
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FDA approved the first generics of Xarelto (rivaroxaban): ?? https://lnkd.in/eTT4UBGc ?? https://lnkd.in/exjz5Yby Read the prescribing information here: https://lnkd.in/ehf4mwXE
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FDA approves an intravenous infusion for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive. To learn more, view the prescribing information: https://lnkd.in/eDZnweAi ALT:
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FDA approved an injection for the treatment of acute ischemic stroke (AIS) in adults. To learn more, view the prescribing information: https://lnkd.in/gZR-gAAg
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FDA informed sponsors of testosterone products about new labeling changes following the agency’s review of the findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial and the results from required postmarket ambulatory blood pressure (ABPM) studies. Testosterone, a hormone essential to the development of male growth and masculine characteristics, is approved solely for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Current FDA-approved testosterone formulations include oral, topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection. Learn more: https://lnkd.in/eixCtan4
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?? Behind every rare disease is a community waiting for breakthroughs. The FDA's ARC program supports the Rare Disease Endpoint Advancement Pilot Program to develop novel endpoints for rare disease drug development. Learn how this program accelerates the availability of treatments for patients with rare disease: https://lnkd.in/euSsTS_A #RareDiseases
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?? Rare disease doesn’t mean rare impact. The FDA’s ARC program is paving the way for accelerated drug development by providing important tools for Learning and Education to ADvance and Empower Rare Disease Drug Developers: https://lnkd.in/eEW-xreB #LEADER3D
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FDA转发了
I so enjoyed my meeting with tribal leaders and elders from my advisory committee. Past administrations have treated Indian Health Service as a red-headed stepchild. This administration will make Indian Country a priority.
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