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Biohaven filed an update on its NDA with the SEC, while the FDA indicated that advisory committee meetings were unnecessary.

2 reports, 2 independent Updated Oct 22
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What happened

Some supportReported by 2 outlets

Biohaven filed an update on its NDA with the SEC, while the FDA indicated that advisory committee meetings were unnecessary.

Who's involved

What this event is mainly about
Food and Drug AdministrationSecurities and Exchange Commission

How it developed

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  1. FDA accepted Biohaven's resubmitted drug application, and the company licensed its portfolio for ASEAN.1 source
  2. Biohaven updates its NDA filing with the SEC following FDA guidance.1 source

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The entities involved

Coverage

Newest first; wire copies grouped
  • insidermonkey.com
  • Motley FoolWhy Biohaven Stock Zoomed More Than 6% Higher Today A top regulator said it wouldn't convene an advisory committee to discuss the biotech's latest application. This is for the company's leading pipel