RAPS

Catalyst Sues FDA Over Approval of Rival Drug

Catalyst Pharmaceuticals on Wednesday sued the US Food and Drug Administration (FDA) because of the agency’s recent approval of rival Jacobus Pharmaceutical Company’s Ruzurgi (amifampridine) for the ...
RAPS

Internal FDA Emails Reveal How Price, Sanders’s Pressure Played a Role in Competitor’s Approval, Catalyst Claims

A series of partially redacted internal emails from the US Food and Drug Administration (FDA), released as part of a lawsuit related to competing treatments for the rare disorder Lambert-Eaton ...

Why The Insight Molecular Diagnostics (IMDX) Story Is Shifting After Cash Raise And FDA Catalyst

The latest update to Insight Molecular Diagnostics has seen the analyst price target move to US$12, while the fair value estimate remains at US$8.33 per share. Analysts linking this shift to the ...