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) ...
The American Journal of Managed Care

Subcutaneous Ocrelizumab and Hyaluronidase Approved for RMS, PPMS

Ocrelizumab and hyaluronidase is now the first and only twice-yearly subcutaneous injection approved for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The ...
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), ...
FOX8 Cleveland

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 ...

Junshi Biosciences Announces NMPA Acceptance of New Drug Applications for Toripalimab Injection (Subcutaneous) Across 12 Indications

Independently developed by Junshi Biosciences, JS001sc injection is a subcutaneous injection based on the marketed product toripalimab injection (code: JS001) that is expected to enhance convenience ...
Seeking Alpha

TREMFYA® (guselkumab) is first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes with a fully subcutaneous regimen through 48 weeks in ...

"For many patients, having a subcutaneous induction option is an important step forward—offering the flexibility of at-home administration after proper training without compromising efficacy," said ...
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 ...
Medical News Today

You ask, we answer: Is subcutaneous immunotherapy an effective treatment for cancer?

A person receives subcutaneous immunotherapy as an injection under the skin. This treatment method has shown similar effectiveness to intravenous (IV) infusions that healthcare professionals often use ...
Medical News Today

Sublocade dosage

Sublocade (buprenorphine) is a brand-name prescription medication. The Food and Drug Administration (FDA) has approved it to treat opioid use disorder in adults, as part of a complete treatment ...
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 ...