Drug Approvals

An approved drug is a formulation that has been validated for a therapeutic use by a ruling regulatory authority. Here, we cover the latest in big drug approvals and explore how these new therapies could impact the industry. 


FDA hands Biohaven refusal to file letter

The company plans to request a Type A meeting with the agency to discuss its spinocerebellar ataxia type 3 treatment
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FDA decisions to watch in 2023

The agency is facing a busy year, with potential novel drug approvals ranging from gene therapies to RSV jabs

10 tips for improved drug development

Comprehensive strategies to save time and reduce cost in end-to-end clinical development

Pulling antibiotics from the fire

Can policy reform save a market in peril?

HIV: An ending in the balance

Incorporating cures into pharma's HIV epidemic equation