USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents

If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine

USFDA Issues a CRL for the Biologics License Application for Insulin Aspart

The CRL did not identify any outstanding scientific issues with the product.

Gamida Cell initiates rolling submission of Biologics License Application for Omidubicel

On track to complete the BLA submission in the first half of 2022

Pfizer and OPKO update on the Biologics License Application for Somatrogon

Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA

Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers

ADMA Biologics wins FDA nod to expand ASCENIV use in young children

FDA pushes forward on gene-editing therapies with new safety roadmap

Genome editing holds extraordinary promise for treating previously incurable genetic diseases

Orca Bio’s Orca-T FDA review extended to July 2026

Sun Pharma scores FDA review for ILUMYA in psoriatic arthritis

ILUMYA has already earned FDA approvals for scalp and nail plaque psoriasis in April 2024 and December 2025

FDA grants priority review to Enhertu for high-risk HER2-positive breast cancer

Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population