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 ...
Companies that make compounded drugs obtain semaglutide API from authorized and registered chemical manufacturers.
MORRISVILLE, NC, UNITED STATES, January 15, 2026 /EINPresswire.com/ — MethodSense, Inc., a leading regulatory and quality consulting firm for the medical device ...
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.
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 ...
Apotex Corp., in partnership with Orbicular Pharmaceutical Technologies Pvt. Ltd. and Gland Pharma Limited, today announced that the U.S. Food and Drug Administration (FDA) has approved two ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results