Business ❯ Corporate Law ❯ Regulatory Compliance

FDA Regulations

Clinical Trials New Drug Application Facility Inspections Drug Approval Process Pharmaceuticals Biologics License Application

6 ARTICLES

9mo ago

Cytokinetics Investors Face Nov. 17 Deadline to Seek Lead Role in Aficamten Securities Case

The pending Northern District of California lawsuit alleges the company misled investors by filing its aficamten NDA without a REMS after FDA discussions, affecting the expected review timeline.

4 ARTICLES

10mo ago

FDA Regulations

Cytokinetics Investors Face Nov. 17 Deadline to Seek Lead Role in Aficamten Securities Case

Investor Firms Urge Cytokinetics Shareholders to Seek Lead Role in FDA-Disclosure Suit Before Nov. 17