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Pharma Now Editorial Team

Pharma Now Editorial Team
Pharma Now Editorial Team
FDA finalizes ICH Q9(R1), targeting subjectivity, formality gaps, and product availability risks in pharmaceutical quality risk management frameworks.
Pharma Now Editorial Team

FDA approves Cefepime/Zidebactam Injection, a novel beta-lactam combination targeting gram-negative pathogens, with sterile manufacturing implications.
Pharma Now Editorial Team

FDA's draft guidance on oncology biologics nonclinical studies introduces single-species testing and weight-of-evidence NHP alternatives. Comment deadline: July 30, 2026.
Pharma Now Editorial Team

J&J submits EMA application for teclistamab indication extension after MajesTEC-9 Phase 3 data show 71% PFS and 40% OS benefit at first relapse.
Pharma Now Editorial Team
