The FDA is reviewing an application seeking expanded approval of an under-the-skin injection version of Leqembi (lecanemab).

– Late-breaking Phase III results show subcutaneous injection was non-inferior to intravenous infusion based on Ocrevus levels in the blood over 12 weeks – – Ocrevus subcutaneous injection was ...

Eisai and Biogen’s Supplemental Biologics License Application (sBLA) for Leqembi (lecanemab) subcutaneous autoinjector (SC-AI) has been accepted by the US FDA under Priority Review to treat early ...

Previously lecanemab was only approved as an SC injection for maintenance dosing, following an initial 18 month IV phase.

Monash University researchers, alongside key partner Halozyme Therapeutics, report findings in support of shifting the way ...

MILAN -- An investigational 10-minute subcutaneous injection of ocrelizumab (Ocrevus) was non-inferior to the established IV infusion formulation of the drug in multiple sclerosis (MS), the phase III ...

Dr. Balazs Halmos discusses the significance of the FDA approval of the subcutaneous injection formulation of Opdivo for patients with solid tumors. The Food and Drug Administration (FDA) approval of ...

Basel, 14 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...

Please provide your email address to receive an email when new articles are posted on . Genentech announced it received FDA approval for Ocrevus Zunovo to treat patients with relapsing and primary ...

Please provide your email address to receive an email when new articles are posted on . Opdivo was previously only available intravenously. The approval comes after CHECKMATE-67T study results. Opdivo ...