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 ...
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 ...
FierceBiotech

Disc set to spin up confirmatory trial, seek approval after ironing out details with FDA

Disc Medicine has finalized the design of the confirmatory trial for its rare blood disorder drug candidate, adding a co-primary endpoint at the request of the FDA to clear the path to accelerated ...
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 ...
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 ...
SlashGear

Disc Vs. Disk: What's The Difference In Tech?

English is such a bizarre language. There are countless instances of pronunciation inconsistencies, idioms exclusive to the language, words that are spelled exactly the same but mean completely ...