Bayer recently received FDA approval for a connected auto-injector for relapsing-remitting multiple sclerosis medication and companion app. The device is called the Betaconnect Electronic Autoinjector ...
The FDA approved dihydroergotamine (DHE) mesylate injection (Brekiya) to treat acute migraine (with or without aura) and cluster headaches in adults, Amneal Pharmaceuticals announced Thursday. The ...
Aiming to deliver blockbuster sales of its Alzheimer’s-disease-fighting antibody Leqembi in its 2027 fiscal year, Eisai has cleared a key regulatory hurdle in its quest to grow the medicine's reach.
Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESAIY) announced the rolling submission of a marketing application to receive an FDA label expansion for a subcutaneous autoinjector that delivers their Alzheimer ...
MORRISVILLE, NC, UNITED STATES, January 15, 2026 /EINPresswire.com/ — MethodSense, Inc., a leading regulatory and quality consulting firm for the medical device ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Collaboration underscores MethodSense’s role in accelerating market access and regulatory confidence for advanced medical device innovations. MORRISVILLE, NC ...
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