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FDA Finalizes ICH Q9(R1) Guidance Targeting Subjectivity and Formality Gaps in Quality Risk Management
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FDA Approves Cefepime/Zidebactam Injection, Raising Sterile Manufacturing and QA Readiness Questions

Pharma Now Editorial Team

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FDA Finalizes ICH Q9(R1) Guidance Targeting Subjectivity and Formality Gaps in Quality Risk Management

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

Pharma Now Editorial Team

Pharma Now

FDA Approves Cefepime/Zidebactam Injection, Raising Sterile Manufacturing and QA Readiness Questions

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

Pharma Now Editorial Team

Pharma Now

FDA Issues Draft Guidance Streamlining Nonclinical Safety Studies for Oncology Biologics

FDA's draft guidance on oncology biologics nonclinical studies introduces single-species testing and weight-of-evidence NHP alternatives.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

Pharma Now

Johnson & Johnson Gains EMA Submission for Teclistamab Indication Extension After Phase 3 MajesTEC-9 OS Win

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

Pharma Now