Disc Medicine Rare Disease Drug Picked for Faster Regulatory Review Is Rejected by the FDA

Disc Medicine Rare Disease Drug Picked for Faster Regulatory Review Is Rejected by the FDA

The FDA asked for more data to determine whether Disc Medicine’s bitopertin is benefiting patients with erythropoietic protoporphyria, a rare blood disorder. Analysts say it’s a surprising delay considering bitopertin is one of the first drugs in a new FDA pilot program that speeds up regulatory review of medicines deemed critical for national security or public health. The post Disc Medicine Rare Disease Drug Picked for Faster Regulatory Review…

FDA turns down 'national priority' drug from Disc Medicine

One of the beneficiaries of the FDA's national priority vouchers, Disc Medicine, has had its marketing application turned down by the regulator.

FDA rejects Disc Medicine's rare disease drug despite granting it a commissioner voucher

The rejection of Disc Medicine’s rare disease treatment marks the first negative outcome of the FDA's controversial voucher program and suggests drugs that are selected won't be guaranteed an approval. Disc's bitopertin was an early ...

FDA issues complete response letter to Disc Medicine’s bitopertin NDA

Disc Medicine has received a CRL from the US FDA concerning its New Drug Application (NDA) for bitopertin for EPP.