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FDA Issues Draft Guidance Streamlining Nonclinical Safety Studies for Oncology Biologics
FDA's draft guidance on oncology biologics nonclinical studies introduces single-species testing and weight-of-evidence NHP alternatives.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
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
Optimi Health Gains Broader Australian Market Access After TGA Revises Authorized Prescriber Framework
TGA revises Australia's Authorized Prescriber scheme, broadening therapist eligibility and treatment settings, expanding demand for Optimi Health's GMP-compliant Canadian supply.
Pharma Now Editorial Team
AbbVie Gains EU Approval for VENCLYXTO Label Expansion Covering Three New CLL Combination Regimens
AbbVie secures EU label expansion for VENCLYXTO covering three new first-line CLL combinations, triggering multi-market labeling and supply chain updates.
Pharma Now Editorial Team
