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Pharma Now Editorial Team
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Shilpa Medicare Commissions Integrated ADC Drug Substance Facility in India for End-to-End CDMO Services
Shilpa Biologicals commissions an integrated ADC Drug Substance facility, joining a small group of Indian CDMOs capable of end-to-end complex biologics manufacturing.
Pharma Now Editorial Team
Octapharma Gains Multiple FDA Approvals for WILATE Across Expanded VWD and Hemophilia A Indications
Octapharma's WILATE has accumulated five FDA approval actions since 2019, covering VWD prophylaxis and hemophilia A, a case study in supplemental BLA management.
Pharma Now Editorial Team
Spark Therapeutics' LUXTURNA BLA History Illustrates FDA's Evolving Gene Therapy Manufacturing Standards
LUXTURNA's dual FDA approval record offers QA and regulatory teams a CMC compliance benchmark for AAV-based gene therapy BLA submissions.
Pharma Now Editorial Team
Merck Gains Repeated FDA Labeling Approvals for VARIVAX Dual-Formulation Varicella Vaccine
Merck's VARIVAX has logged six-plus FDA labeling approvals since 2017, illustrating the regulatory lifecycle burden of dual-formulation biological products.
Pharma Now Editorial Team
