The US Food and Drug Administration (FDA) in 2019, has approved an increasing number of orphan drugs and biologics, as well as drugs targeted at specific cancers. The Center for Drug Evaluation and Research (CDER) has reported that this value was more than twice compared to the past eight years. Worldwide orphan drug sales are […]

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Financial benefits, faster approvals, and less stringent clinical data requirements are some important benefits that regulatory agencies across the world offer as incentives for the development of orphan drugs for rare diseases. These countries include the US, Europe, Japan, Australia, South Korea, Brazil, and most recently, India. These incentives have been so supportive and convincingly […]

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