TOKYO/CAMBRIDGE - The U.S. Food and Drug Administration has accepted Eisai’s application for a subcutaneous autoinjector version of its Alzheimer’s treatment lecanemab-irmb (LEQEMBI) under priority ...
A newly developed autoinjector is described as a “major leap forward in how autoinjectors are developed, customized, and scaled,” according to contract development and manufacturing organization (CDMO ...
Celltrion said on the 18th that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) recommended approval of a variation application to add an ...
SteQeyma ™ 45mg and 90mg solution for injection via autoinjector (pre-filled pen) receives positive CHMP opinion, which will facilitate subcutaneous administration in patients with plaque psoriasis, ...
Please provide your email address to receive an email when new articles are posted on . Feasibility and acceptability scores for the autoinjector were highest among health care professionals. All ...
MannKind Corporation delivered strong Q3 '25 results, beating EPS and revenue estimates, and shares have responded positively. The FDA accepted the supplemental New Drug Application for the FUROSCIX ...
WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the ...
The auto injector market represents a rapidly expanding segment within the global pharmaceutical delivery systems industry, driven by the increasing prevalence of chronic diseases and the growing ...
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 ...
Auto-injector specialist Ypsomed is hopping on the U.S. manufacturing bandwagon, investing 200 million Swiss francs ($248 million) to build a plant in Holly Springs, North Carolina. It will be the ...
A new study shows that a TXA autoinjector delivers lifesaving treatment for severe bleeding as effectively as traditional IV methods — but in under five minutes and without the need for medical ...
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 ...
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