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Results For "BLA"

416 News Found

Roche’s Lunsumio VELO–Polivy combo moves closer to FDA decision after strong lymphoma trial results
News | June 23, 2026

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


WuXi Biologics wins fourth EMA certification for Suzhou Biosafety Center
News | June 23, 2026

WuXi Biologics wins fourth EMA certification for Suzhou Biosafety Center

Clearing 19 biologics for Europe market


FDA fast-tracks Roche cancer drug filing after landmark trial shows 50% recurrence reduction
Drug Approval | June 23, 2026

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


Automated cell therapy manufacturing attracts US$1.1 Billion  across 34 funding rounds
Biopharma | June 20, 2026

Automated cell therapy manufacturing attracts US$1.1 Billion across 34 funding rounds

New Tracxn report highlights growing investor confidence in automated cell therapy production, with Cellares and Ori Biotech dominating funding and regulatory milestones


AngioDynamics gets FDA nod for RELIEF trial to evaluate NanoKnife for enlarged prostate treatment
Medical Device | June 19, 2026

AngioDynamics gets FDA nod for RELIEF trial to evaluate NanoKnife for enlarged prostate treatment

Study will assess the safety and effectiveness of irreversible electroporation as a minimally invasive treatment option for benign prostatic hyperplasia (BPH)


Medtronic launches PulseSelect PFA system in India
Medical Device | June 15, 2026

Medtronic launches PulseSelect PFA system in India

New-generation cardiac ablation technology expands treatment options for atrial fibrillation patients, offering a non-thermal approach to improve safety and procedural efficiency


FibroFind appoints Lee Borthwick as CEO to drive global expansion
People | June 10, 2026

FibroFind appoints Lee Borthwick as CEO to drive global expansion

Preclinical CRO strengthens leadership team with key executive appointments as it scales its human tissue-based drug discovery platform


AbbVie showcases broad blood cancer pipeline at EHA 2026 with 21 presentations
Clinical Trials | June 09, 2026

AbbVie showcases broad blood cancer pipeline at EHA 2026 with 21 presentations

The company will present 21 oral and poster presentations spanning investigational and approved therapies


Johnson & Johnson brings India’s first PFA technology for atrial fibrillation treatment
Medical Device | June 03, 2026

Johnson & Johnson brings India’s first PFA technology for atrial fibrillation treatment

New platform integrates advanced cardiac mapping and ablation workflow, offering a novel treatment option for AFib patients at risk of stroke and heart failure


Aragen scales Renaissance Pharma’s cancer antibody to commercial GMP in just 9 months
Biopharma | June 02, 2026

Aragen scales Renaissance Pharma’s cancer antibody to commercial GMP in just 9 months

Anti-GD2 monoclonal antibody for high-risk neuroblastoma advances toward BLA submission following successful tech transfer from California to Bengaluru