By Siddhi Mahatole Feb 17 (Reuters) - Disc Medicine said on Tuesday it will pursue a traditional U.S. approval pathway for ...
Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the ...
FDA acknowledged that AURORA and BEACON provided sufficient evidence that bitopertin significantly lowers PPIX and that there is a strong ...
The FDA in October 2025 granted bitopertin its Commissioner’s National Priority Voucher but after a shortened review time has decided the data did not support regulatory approval for treating ...
One of the beneficiaries of the FDA's national priority vouchers, Disc Medicine, has had its marketing application turned ...
The FDA has rejected a rare blood disease candidate from Disc Medicine, a compound that been granted expedited review through ...
Feb 17 () - Disc Medicine said on Tuesday it will pursue a traditional U. approval pathway for its rare disease drug ...
By Sneha S K Feb 13 (Reuters) - Disc Medicine said on Friday the U.S. Food and Drug Administration declined to approve its ...
Disc Medicine received a Complete Response Letter (CRL) from FDA for its New Drug Application (NDA) for bitopertin as a treatment for erythropoietic protoporphyria (EPP), delaying a potential ...
The Johnny Roberts Disc Golf Course in Arvada was the most-played course in the United States last year, according to an analysis by the disc golf app UDisc. This marks the first time that a Colorado ...
A bulging disc in the neck occurs when the gel-like center of a spinal disc protrudes into the spinal cord. This can cause pain in the neck, shoulders, arms, and back. Certain exercises or stretches ...
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