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 ...
Nasdaq

FDA approves OCREVUS ZUNOVO™ as the first and only twice-a-year 10-minute subcutaneous injection for people with relapsing and progressive multiple sclerosis

Basel, 16 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the United States Food and Drug Administration (U.S. FDA) has approved OCREVUS ZUNOVO™ (ocrelizumab & hyaluronidase-ocsq) ...
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), ...
KTLA

ZYMFENTRA™(infliximab-dyyb), the first and only FDA-approved subcutaneous infliximab, now commercially available in the U.S.

JERSEY CITY, N.J., March 17, 2024 /PRNewswire/ -- Celltrion USA announced today the availability of a ZYMFENTRA™ (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab. [1] ZYMFENTRA is the ...
Seeking Alpha

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

LEQEMBI IQLIK will be launched on October 6, 2025, in the U.S. TOKYO and CAMBRIDGE, Mass., Aug. 29, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO ...
Medical News Today

New subcutaneous PD-1 injection for the treatment of cancer

PD-1 inhibitors belong to a class of medications known as immune checkpoint inhibitors, which have become an important part of many modern cancer treatment plans. PD-1 inhibitors work by helping the ...
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 ...
Benzinga.com

Roche's Approved Multiple Sclerosis Drug: Subcutaneous Injection At Par With Intravenous Infusion

Roche Holdings AG's (OTC:RHHBY) Phase 3 OCARINA II trial evaluating Ocrevus (ocrelizumab) as a twice-a-year 10-minute subcutaneous injection met its primary and secondary endpoints in patients with ...
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 ...
Business Wire

FDA Approves Genentech’s Tecentriq Hybreza, the First and Only Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

– Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous (IV) Tecentriq – – New subcutaneous (SC ...