The FDA provided guidance on the design of the APOLLO post-marketing confirmatory trial, which will support an accelerated approval filing for bitopertin. Disc plans to submit a New Drug ...

today announced positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the APOLLO post-marketing confirmatory trial for bitopertin in EPP.

Disc Medicine finalised the pivotal Phase III trial design of bitopertin in erythropoietic protoporphyria (EPP) with the FDA earlier this week.

has received FDA 510(k) clearance for ApolloHipX™, a next-generation THA application designed for the Corin Apollo™ platform. ApolloHipX™ is the first and only hip arthroplasty technology to ...

The recent FDA Type C meeting resulted in an alignment on dual primary endpoints for the APOLLO trial, which include reduction in PPIX and the average final month time spent in sunlight without pain.

Disc Medicine (IRON) announced positive feedback from its Type C meeting with the U.S. Food and Drug Administration, FDA, to discuss the APOLLO post-marketing confirmatory trial for bitopertin in EPP.