Novo Nordisk files 14 new lawsuits against unapproved semaglutide drugs

These filings come after FDA issued its latest warning to patients and healthcare professionals about the serious dangers of compounded GLP-1 drugs

Vertex faces regulatory delays for Journavx and reports VX-993 Phase 2 trial failure

Treatment with the selective NaV1.8 pain signal inhibitor VX-993 after bunionectomy surgery did not meet the primary endpoint

Sanofi’s GPRC5D monoclonal antibody earns ODD in US for multiple myeloma

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