Disc Medicine Receives Complete Response Letter from FDA for Bitopertin for the Treatment of EPP
Disc Medicine Inc FDA acknowledged that AURORA and BEACON provided sufficient evidence that bitopertin significantly lowers PPIX and…
Exclusive-US FDA delays two drug reviews in new voucher program after safety, efficacy concerns
Jan 15 (Reuters) – The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for…
Why Disc Medicine (IRON) Is Up 28.7% After Securing FDA Priority Review for Bitopertin Accelerated Approval
Disc Medicine announced it received a Commissioner’s National Priority Voucher from the US FDA for bitopertin in erythropoietic…