After complete response letter, Lexicon triggers rarely used mechanism for formal hearing, prompting US FDA to publicly list its problems with the proposed type 1 diabetes drug, for which Sanofi had originally sought approval.
Lexicon Pharmaceuticals, Inc. expects to request a formal hearing to overturn the US Food and Drug Administration’s rejection of sotagliflozin in type 1 diabetes, and clarify the product’s prospects in the disease.
The company is able to request a hearing with the FDA commissioner after a series of complete response letter appeals...
Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
