- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
The FDA reviewed the NDA for Disc Medicine, Inc., which required additional evidence on May 26, 2026.
8 reports, 3 independent
Updated Sep 1
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- Reports
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- Repetition
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New informationRepeats or wire copies
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What happened
The FDA reviewed the NDA for Disc Medicine, Inc., which required additional evidence on May 26, 2026.
Who's involved
What this event is mainly aboutKeep exploring
Part of
A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Also in this story
- A partnership with BARDA has accelerated the development of SCY-247 for the company.
- A company plans to submit regulatory applications to the FDA, EMA, and Australian TGA.
- Approval leads to procurement process initiation.
- UroGen Pharma Ltd., headquartered in Princeton, is seeking FDA approval for its products for the U.S. market.
The entities involved
Related events
- FDA approval supports NDA submission in Aurora.
- FDA issued a Complete Response Letter (CRL) regarding Disc Medicine, Inc.'s bitopertin program.
- Takeda is seeking FDA approval for its drug ORZEYFUL.
- The Charlotte Lozier Institute found that the FDA lacked sufficient evidence in its review process.
- Arcutis Biotherapeutics submitted a supplemental New Drug Application (sNDA) to the FDA to expand the indication for its drug ZORYVE.
Coverage
Newest first; wire copies grouped- stockhouse.com
- GlobeNewswireDisc Medicine Reports Second Quarter 2025 Financial Results and Provides Business Update Company on track to submit NDA for bitopertin in erythropoietic protoporphyria (EPP) under accelerated approva
- Insider MonkeyDisc Medicine, Inc. (IRON) Set to Submit NDA for Bitopertin in October 2025 We recently compiled a list of 10 Best Mid Cap Stocks to Buy According to Billionaires. Disc Medicine, Inc. stands sixth on
- GlobeNewswireDisc Medicine Announces Positive Pre-NDA Meeting and Confirms Plans to Submit NDA for Bitopertin in Erythropoietic Protoporphyria (EPP) in October 2025 WATERTOWN, Mass., July 21, 2025 (GLOBE NEWSWIRE