July 18, 2023

First Oral Medication to Treat Moderate-to-Severe Crohn’s Disease Earns FDA Approval

Upadacitinib, the first oral treatment for Crohn's disease, has been approved by the Food and Drug Administration. The approval came in part through a Mount Sinai-led clinical trial that showed it to be more efficacious than placebo.

Mount Sinai New York

February 21, 2024

FDA Approves Biweekly Teclistamab Dosing Regimen for Patients With Multiple Myeloma

On February 20, the FDA approved the supplemental biologics license application for teclistamab-cqyv (Tecvayli) for a reduced dosing frequency of 1.5 mg/kg every 2 weeks in patients with relapsed or r...

The ASCO Post

June 21, 2023

FDA Launches Pilot Program to Help Reduce Risks Associated With Using Laboratory Developed Tests to Identify Cancer Biomarkers

The U.S. Food and Drug Administration (FDA) announced a new voluntary pilot program to help physicians select safe and effective cancer treatments, with guidance on in vitro companion diagnostic tests...

The ASCO Post

November 17, 2023

FDA Approves Capivasertib With Fulvestrant for Breast Cancer

On November 16, 2023, the U.S. Food and Drug Administration (FDA) approved capivasertib (Truqap) with fulvestrant for adult patients with hormone receptor–positive, HER2-negative locally advanced or m...

The ASCO Post

August 29, 2023

FDA Approves Luspatercept-aamt as First-Line Treatment for Adult Patients With Lower-Risk MDS and Anemia Who May Require Transfusions

On August 28, the U.S. Food and Drug Administration (FDA) approved luspatercept-aamt (Reblozyl) to treat anemia in adult patients with very low– to intermediate-risk myelodysplastic syndromes (MDS) wh...

The ASCO Post

August 16, 2024

FDA OCE Invites Pediatric Cancer Advocates to Meet on October 15

The FDA's Oncology Center of Excellence (OCE) Pediatric Oncology Program invites members of the pediatric cancer advocacy community to participate in the 2024 OCE Pediatric Advocacy Forum on October 1...

The ASCO Post

August 28, 2024

FDA Approves Cancer Biomarker Test, Companion Diagnostic Indications

The FDA has approved the in vitro diagnostic TruSight Oncology Comprehensive test and its first two companion diagnostic indications. This targeted sequencing panel interrogates over 500 genes to prof...

The ASCO Post

April 24, 2024

Imaging Drug to Assist in Detection of Cancerous Tissue Following Lumpectomy Approved

Recently, the FDA approved pegulicianine (Lumisight) for adult patients with breast cancer to assist in the intraoperative detection of cancerous tissue within the resection cavity following removal o...

The ASCO Post

March 28, 2024

Amivantamab-vmjw in NSCLC With EGFR Exon 20 Insertion Mutations

On March 1, 2024, amivantamab-vmjw (Rybrevant) was approved for use with carboplatin and pemetrexed for first-line treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) with E...

The ASCO Post