BioSpace

Disc’s Regulatory Comeback Plan for Rejected Drug Relies on Old FDA Leadership

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 ...

Disc Medicine eyes standard US approval for drug after FDA denies fast-track nod

By Siddhi Mahatole Feb 17 (Reuters) - Disc Medicine said on Tuesday it will pursue a traditional U.S. approval pathway for ...
Fierce Biotech

FDA rejects Disc's rare disease drug despite commissioner's voucher

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

FDA Rejects Disc’s Rare Blood Disease Drug Amid Reports of Prasad’s Skepticism

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 ...

US FDA declines to approve Disc Medicine's 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 ...
pharmaphorum

FDA turns down 'national priority' drug from Disc Medicine

A complete response letter (CRL) was sent by the FDA for Disc's bitopertin for erythropoietic protoporphyria (EPP), which was ...
PharmExec

FDA Issues CRL to Disc Medicine for Eythropoietic Protoporphyria Treatment Bitopertin

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 ...

Disc Medicine to pursue traditional U.S. approval after FDA rejects new fast-track route

Feb 17 () - Disc Medicine said ‌on Tuesday it ‌will pursue a traditional ​U. approval pathway for its rare disease drug ...
CNN

PS5 Disc or PS5 Digital Edition? We’ll help you pick

The PlayStation 5 is finally easy to find after years of scarcity, but before you hit that “add to cart” button, you’ll still have to make an important decision: PS5 Disc or PS5 Digital Edition? And ...