Nuvation BIO is happy to share that the US Food and Drug Administration (FDA) has approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This exciting approval provides a new targeted tyrosine kinase inhibitor (TKI) for patients with this rare and aggressive disease. Please see full Prescribing Information. Uncover more about IBTROZI and learn how this new TKI may help ROS1+ NSCLC patients.

Paris, June 3, 2025. New data from two clinical studies of the investigational use of Sarclisa administered subcutaneously (SC) via an on-body injector (OBI) (also referred to as an on-body delivery system) in relapsed or refractory multiple myeloma (R/R MM) support the potential use of this innovative delivery method to advance patient care, while upholding Sarclisa’s efficacy and safety profile.

On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.

BAAR, Switzerland--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) announced today that Optune Lua® has received a CE (Conformité Européenne) Mark for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) concurrently with immune checkpoint inhibitors or docetaxel who have progressed on or after a platinum-based regimen.

BOSTON, January 17, 2025 - Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Day One Biopharmaceuticals’ OJEMDA, a type II RAF inhibitor, for the treatment of patients six months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

The first interim analysis of the Phase 2 COCOON study met its primary endpoint, demonstrating that an easy-to-use and readily available regimen significantly reduced the frequency of moderate-to-severe skin and nail side effects (Grade 2 or higher) and severity of skin-related side effects compared to standard dermatological management in patients receiving first-line treatment with RYBREVANT® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib).

RARITAN, N.J., January 15, 2025 – 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-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.