Clene, Inc.

Real-world evidence from expanded access programs and a natural history external control played important roles in recent US FDA decisions on the suitability of the accelerated approval pathway for C

The US Food and Drug Administration is under new pressure from Congress to consider “survivability” as an endpoint that could be used for accelerated approval, and Clene, Inc. ’s ALS drug could quick

Shortly after a Phase III trial failed to confirm Amylyx Pharmaceuticals, Inc. ’s Relyvrio benefit in amyotrophic lateral sclerosis (ALS), Seelos Therapeutics, Inc. has revealed that its investigat

The usual pattern of reporting positive clinical trial results or winning US Food and Drug Administration approval then launching a large follow-on public offering (FOPO) has become less common under