Review
Open access
2026
Global Regulatory Landscape of Orphan Drug Development: An Evaluation of Market Authorizations, Therapeutic Areas and Sponsor Companies
Rare diseases represent a significant global healthcare challenge due to their low prevalence, delayed diagnosis, limited treatment options, and high treatment costs. Orphan drugs have emerged as an essential therapeutic approach to address these unmet medical needs; however, their development and market authorization...
Dipti Vilas Sonawane, Pranjal Pramod Chaudhary, A. Bhalerao et al.
· International Journal of Cur... · 0 citations