A new guidance document released this week provides the US Food and Drug Administration's (FDA) recommendations for sponsors who choose to develop a type of combination product known as pen/jet ...
The US Food and Drug Administration on Thursday approved Teva Pharmaceuticals’ first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic ...
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 ...
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 ...
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.
MORRISVILLE, NC, UNITED STATES, January 15, 2026 /EINPresswire.com/ — MethodSense, Inc., a leading regulatory and quality consulting firm for the medical device ...
Companies that make compounded drugs obtain semaglutide API from authorized and registered chemical manufacturers.
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