BridgeBio Gets First Drug Approval In Ultra-Rare MoCD Type A
Although small patient base offers modest revenue opportunity, the Nulibry approval enables BridgeBio to get commercial operations underway.
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BridgeBio and US FDA agreed on a path to accelerated approval for BB-418, a Phase III oral candidate for a subset of limb-girdle MD patients. If successful, it would bring BridgeBio’s third product to market.
The sponsors of six drugs that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.
The sponsors of four drugs were due or possibly due to appear before the European Medicines Agency to explain why their respective products merit EU-wide approval.