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 ...

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 ...

- UDENYCA ® is the only pegfilgrastim therapy delivered in a convenient, easy-to-administer prefilled autoinjector to offer in-clinic and at-home administration options for cancer patients undergoing ...

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 ...

EpiPen will face competition in a generic version of the auto-injector marketed by Teva Pharmaceuticals and approved by the U.S. Food and Drug Administration on Thursday. The FDA previously approved ...

MORRISVILLE, NC, UNITED STATES, January 15, 2026 /EINPresswire.com/ — MethodSense, Inc., a leading regulatory and quality consulting firm for the medical device ...

Collaboration underscores MethodSense’s role in accelerating market access and regulatory confidence for advanced medical device innovations. MORRISVILLE, NC ...