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FDA Regulations

Product Safety Drug Approval Process Manufacturing Practices Biologics License Application Cytokinetics, Incorporated Health Standards Drug Approval Processes New Drug Application

DexCom Investor Suits Intensify as Firms Set Competing Lead-Plaintiff Deadlines

Plaintiffs frame the dispute around unapproved sensor changes that allegedly degraded device accuracy.

DexCom Faces Wave of Securities Class Actions Over FDA-Faulted CGM Changes

Cytokinetics Investors Urged to Act as Lead‑Plaintiff Deadline Nears in REMS‑Related Securities Suit