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

FDA advisory panel backs Moderna flu vaccine candidate for older adults

The backing comes as influenza remains a persistent public health burden

FDA clears 131 drugs as global pharma approval momentum rebounds in 2025

After a volatile decade in which approvals swung sharply from year to year, 2025’s total pushed past long-term norms, exceeding the 10-year average

Roche’s Lunsumio VELO–Polivy combo moves closer to FDA decision after strong lymphoma trial results

The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines

FDA fast-tracks Roche cancer drug filing after landmark trial shows 50% recurrence reduction

The FDA has granted Priority Review, setting a target decision date of 9 October 2026, potentially accelerating access to a new treatment option for a subset of patients with high-risk colon cancer characterized

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