Incyte (INCY) and Syndax Pharmaceuticals (SNDX) have received FDA approval for their drug Niktimvo in 9 mg and 22 mg vial sizes. Read more here.

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United States

Incyte, Syndax get FDA okay for 9 mg, 22 mg Niktimvo vials

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– U.S. launch expected in early February –

TBNweekly

Incyte and Syndax Announce U.S. Food and Drug Administration (FDA) Approval of Niktimvo™ (axatilimab-csfr) 9 mg and 22 mg Vial Sizes

Incyte and Syndax's Niktimvo becomes first FDA-approved CSF-1R targeting therapy for chronic GVHD, demonstrating remarkable 75% response rate in patients failing prior treatments.

stocktitan.net

FDA Approves Niktimvo: Breakthrough Treatment for Chronic GVHD Shows 75% Response Rate

An NDA has been submitted to the FDA seeking the approval of TAR-200 for BCG-unresponsive high-risk NMIBC with CIS, with or without papillary tumors.

onclive.com

FDA Approval Is Sought for TAR-200 in BCG-Unresponsive High-Risk NMIBC With CIS

The approval was based on data from the phase 3 VIVID-1 study and marks mirikizumab’s second approval in IBD, the first being ulcerative colitis in 2023.

hcplive.com

FDA Approves Mirikizumab (Omvoh) for Crohn’s Disease

An FDA application for TAR-200 to treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer is under real-time oncology review, expediting access to this potential treatment.

targetedonc.com

FDA Considers TAR-200 in BCG-Unresponsive High-Risk NMIBC

Data from the phase 2b SunRISe-1 study support the NDA for TAR-200 in patients with BCG-unresponsive high-risk non–muscle-invasive bladder cancer with CIS.

cancernetwork.com

FDA Receives NDA for TAR-200 in BCG-Unresponsive High-Risk NMIBC

Application accepted for U.S. FDA Real-Time Oncology Review (RTOR) based on Phase 2b SunRISe-1 study showing highest single-agent complete response rate of 83.5 percent1 RARITAN, NJ – Johnson & Johnson (NYSE: JNJ) announced it has initiated the submission of an original New Drug Application with the U.S. Food and Drug Administration (FDA) for TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-mus…

lifesciencesbc.ca

New Drug Application Initiated with U.S. FDA for TAR-200, the First and Only Intravesical Drug Releasing System for Patients with BCG-unresponsive High-risk Non-muscle-invasive Bladder Cancer - Life Sciences British Columbia

Incyte, Syndax get FDA okay for 9 mg, 22 mg Niktimvo vials

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