Roche's Obesity Drug Helps Almost 87% People Lose At Least 10% Weight

Roche released Phase 2 trial results showing its weekly obesity drug CT-388 helped patients lose up to 22.5% body weight with ...
MedPage Today

Subcutaneous Ocrelizumab Not Inferior to IV Infusion

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 ...
Neurology Advisor

Subcutaneous Lecanemab Starting Dose Under Review for Alzheimer Disease

The FDA has accepted for review the sBLA for subcutaneous lecanemab-irmb as a weekly starting dose for Alzheimer disease.
Cure Today

Delving into Subcutaneous Versus Intravenous Opdivo in Solid Tumors

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 ...
Healio

FDA approves Opdivo as subcutaneous injection

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 ...
The Manila Times

FDA Accepts LEQEMBI® IQLIK™ (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s …

If approved, LEQEMBI IQLIK would be the first and only anti-amyloid treatment to offer at-home injection options for ...

Leqembi® Iqlik™ (lecanemab-irmb) supplemental Biologics License Application regarding subcutaneous starting dose granted Priority Review by the US FDA

BioArctic AB's (publ) (STO: BIOA B) partner Eisai announced today that the supplemental Biologics License Application (sBLA) for Leqembi Iqlik subcutaneous autoinjector (SC-AI) as a weekly starting ...
FiercePharma

Roche preps for filings after subcutaneous Ocrevus matches up to IV formulation in phase 3 study

Roche’s subcutaneous version of its multiple sclerosis (MS) med Ocrevus triumphed in a key late-stage study, likely setting up a new opportunity for the blockbuster drug. The study, called OCARINA II, ...
PMLive

Eisai and Biogen’s subcutaneous Leqembi given FDA Priority Review for early Alzheimer’s

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 ...
Nasdaq

Roche’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types

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 ...
Business Wire

Genentech’s Ocrevus Twice-Yearly, 10-Minute Subcutaneous Injection Was Non-Inferior to Intravenous Infusion and Provided Near-Complete Suppression of Brain Lesions

– 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 ...

FDA Accepts LEQEMBI® IQLIKTM (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease under ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced ...