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OPKO and Entera plan to file IND application for their respective drugs.

1 report, 0 independent Updated Jun 25

AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.

What happened

SpeculativeNo independent reporting found

Who's involved

What this event is mainly about

FDA BMD

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The entities involved

FDA
- Generic medicine services are seeking approval for launch from the FDA.Mon 17:49
- A company is seeking FDA feedback on its NEO212 program, with a meeting scheduled at the FDA's White Oak campus.Mon 14:56
BMD
company

Nothing else this week.

Related events

IGC Pharma, Inc. is preparing data for potential U.S. FDA review and seeking EMA support for its lead drug candidate.Aug 11
The FDA placed a clinical hold on the IND application for the company Aardvark.Jul 30
NewcelX Ltd. advanced its IND-enabling work for a Phase 1/2a trial and held a successful Type B Pre-IND meeting with the FDA.Mon 14:50

Coverage

Newest first; wire copies grouped

Jun 25Unknown outlet