FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease

Godavari Biorefineries ED Sangeeta Srivastava named BRSI Honorary Fellow

Dr Srivastava was selected by an expert jury in recognition of her sustained contributions to renewable chemicals, industrial biotechnology and bioprocess innovation

Pharma overhaul: EMA hails “Once-in-a-Generation” reform

The reform is set to modernise how medicines are developed, authorised, and made available across the EU

Sanofi secures two breakthrough nods in China for rare blood disorders

Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia

Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga

Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility

Eiko LifeSciences to acquire 51% stake in SSM Formulations

The plant can reach an annual capacity of 300 crore tablets and 90 crore capsules

Emcure Pharmaceuticals appoints Barnona Basu as Director – Marketing (India)

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483

EMA backs higher-dose Wegovy, clearing path for greater weight loss option in Europe

Lupin Manufacturing Solutions partners with PolyPeptide to scale global peptide supply chain

This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets