The FDA has rejected a rare blood disease candidate from Disc Medicine, a compound that been granted expedited review through ...

Synergy Spine Solutions earned the FDA’s premarket approval for its Synergy Disc, according to a Feb. 27 news release. The device is approved for 1-level cervical disc replacement at C3 to C7 for ...

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 ...

Synergy Spine Solutions announced today that it received FDA premarket approval (PMA) for its Synergy Disc for 1-level indications at C3-C7.

Pursuing a traditional approval path for bitopertin in erythropoietic protoporphyria (EPP); Phase 3 APOLLO study is expected to complete ...

The FDA has rejected a rare disease therapy from Disc Medicine, an early recipient of a commissioner's voucher from the ...

Disc Medicine Inc. IRON shares closed around 22% lower on Friday as the company navigates a regulatory hiccup with a Complete ...

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’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 ...

Degenerative disc disease (DDD) and intervertebral disc degeneration (IVDD) represent conditions that impair the function of the spinal motion segments, profoundly affecting quality of life worldwide.

Degeneration of the intervertebral disc, often called degenerative disc disease of the spine, is a condition that can be painful and greatly affect the quality of one's life. And while disc ...