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 ...
- 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 ...
On Monday, the FDA accepted Eisai Co., Ltd. (OTC:ESALY) and Biogen Inc’s (NASDAQ:BIIB) Biologics License Application (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector (SC-AI) for weekly ...
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 ...
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 ...
Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. FDA has accepted Eisai's Biologics License Application for lecanemab-irmb, marketed as LEQEMBI, which is designed for subcutaneous ...
Regeneron Pharmaceuticals (NASDAQ:REGN) announced that the U.S. FDA has extended the target action dates for two regulatory submissions related to Eylea HD (aflibercept) injection 8 mg to the fourth ...
MORRISVILLE, NC, UNITED STATES, January 15, 2026 /EINPresswire.com/ — MethodSense, Inc., a leading regulatory and quality consulting firm for the medical device ...