The FDA Wants to Pull Its Approval of a Drug. It’s Not So Easy.

Coverage, in order

1. 14d ago
   
   first Undark indie

   The FDA Wants to Pull Its Approval of a Drug. It’s Not So Easy.

   In 2021, the FDA was on the fence about whether to approve a new treatment for a rare form of vasculitis. After an advisory committee narrowly recommended approval, the agency greenlit the drug, Tavneos, and it started making its way into clinics. After uncovering evidence of what it says is data…

2. 11d ago
   
   Ars Technica Science indie study

   The FDA wants to pull its approval of a drug. It’s not so easy.

   In May 2021, the US Food and Drug Administration released a lengthy briefing document on an experimental medication for a rare autoimmune form of vasculitis that often damages the kidneys and lungs. The agency was on the fence about whether to approve the treatment, and it wanted an independent…

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