Roche updates on Elevidys gene therapy for Duchenne muscular dystrophy in EU

Elevidys is currently the only approved gene therapy that targets the root cause of Duchenne

Imfinzi granted Priority Review and Breakthrough Therapy Designation in US

For patients with resectable early-stage gastric and gastroesophageal junction cancers

Akums’ Haridwar factory receives ANVISA GMP certification for sterile manufacturing plant

This certification validates the plant’s robust capabilities in manufacturing a wide range of sterile dosage forms

Sigachi Industries begins disbursing Interim ex-gratia to families of deceased

EMA’s CHMP recommends authorization of Moderna's Covid-19 vaccine Spikevax for SARS-CoV-2 Variant LP.8.1

Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision

Concord Biotech successfully completes Russian GMP inspection at its API facility

The inspection was conducted from July 22-25, 2025

Pfizer completes licensing agreement with 3SBio to expand oncology portfolio

3SBio will receive a payment of $1.25 billion. Pfizer will also make a $100 million equity investment in 3SBio

Sun Pharma’s phase 3 Cclinical studies for Tildrakizumab 100 mg meet primary endpoint

The INSPIRE-1 and INSPIRE-2 trials are Phase 3 studies assessing the efficacy and safety of tildrakizumab 100 mg (ILUMYA) in adults with active psoriatic arthritis (PsA)

Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys

FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths

Miltenyi Biotec and THSTI partner to launch CAR-T Cell and gene therapy training curriculum

This collaboration aims to bridge India’s talent and translational gap in this rapidly growing field by equipping professionals with practical expertise in the manufacturing of advanced therapies.