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Clinical Overview of Innovative New Drug Approvals in
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New drugs, NCEs, Biologics, Fast-track, First-in-class, Orphan drugs, Block-buster drugsAbstract
The FDA has approved 46 new drugs in , another record approval in two decades on a similar pace to the gangbuster year of Many of these new medicines address significant and meaningful needs, or offer additional therapeutic choices for patients worldwide. These new drugs also cover a broad range of indications including immuno-oncology (Imfinzi and Bavencio), Parkinson’s disease (Xadago), eczema (Dupixent), psoriasis (Siliq and Tremfya), multiple sclerosis (Ocrevus), and different types of cancer (Idhifa, Aliqopa, Calquence, and Besponsa). A few important orphan drugs were approved, including in mucopoly-saccharidosis type VII (Mepsevil) and Batten’s Disease (Brineuria). Many of these new drugs are for rare diseases and sub-types of cancer, which often target very small populations, although they can cost hundreds of thousands of dollars. Yet the pharma companies saw average returns on their research and development spending fall, reflecting more competiti
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Bio - Data: Personal Details
Bio - Data: Personal Details