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Regulatory
FDA Novel Drug Therapy Approvals for 2025 | Quarter 4
Regulatory
FDA Approves New Gene Therapy for Spinal Muscular Atrophy (SMA)
Regulatory
Accord BioPharma Announces FDA Approval of Denosumab Biosimilars
Regulatory
FDA Publishes Filing Checklists to Prevent Submission Delays
Regulatory
SciKonnect Offers End-to-End Regulatory Support for Healthcare industry
Regulatory
FDA Approval for First Nasal Spray Loop Diuretic for Edema
Regulatory
Biocon Biologics Wins FDA Nod for Denosumab Biosimilars Bosaya™ and Aukelso™
Regulatory
FDA update: No More Costly Clinical Efficacy Studies
Regulatory
Lupin Secures FDA Nod for Liraglutide and Glucagon Injectables
Regulatory
FDA to Revoke 52 Obsolete Food Standards
Regulatory
Upcoming FDA Meeting: BsUFA III Regulatory Science Program
Regulatory
FDA Unveils Streamlined Guidelines for Biosimilar Industry Meetings
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