Business Wire

Zai Lab Announces Acceptance of Supplemental Biologics License Application with Priority Review for Efgartigimod Alfa Injection (Subcutaneous Injection) in Chronic Inflammatory ...

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration ...
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.
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 ...
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 ...
The American Journal of Managed Care

FDA Accepts Nivolumab Subcutaneous Injection Application, With Potential to Boost Access to PD-1 Inhibitors

Some experts believe offering a subcutaneous version of nivolumab could make PD-1 inhibitors available to new groups of patients who currently lack access, such as those in rural areas. This article ...
Nasdaq

FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease

LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease after initial ...

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 ...
Mirage News

Monash: Hyaluronidase Boosts Cancer Immunotherapy

Monash University researchers alongside key partner Halozyme Therapeutics have reported findings in support of shifting the way anti-cancer ...
Nasdaq

FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy

Basel, 13 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq HybrezaTM (atezolizumab and hyaluronidase-tqjs), ...
Cure Today

What Subcutaneous Keytruda Means for Patients With Melanoma

Keytruda Qlex is now FDA-approved for subcutaneous use in patients 12 and older with solid tumors, offering an alternative to IV administration. Subcutaneous administration can improve patient ...
Seeking Alpha

TREMFYA® (guselkumab) achieves U.S. approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen

TREMFYA ® offers the flexibility of self-administration from the start of treatment, building on the prior approval of subcutaneous induction in Crohn's disease TREMFYA ® achieved significant rates of ...