FDA accepts supplemental Biologics License Application for Roche’s Columvi combination

For people with relapsed or refractory diffuse large B-cell lymphoma

NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer

If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy

USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer

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

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

Pfizer’s HYMPAVZI bags FDA priority review, targeting younger & hard-to-treat hemophilia patients

HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors

AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer

The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)