FDA Regulations

Drug Approval Process Biologics License Application New Drug Application Corporate Inspections Drug Safety Risk Evaluation Citizen Petitions Risk Management Product Safety Risk Evaluation and Mitigation Strategy (REMS) Cosmetic Products

6 ARTICLES

3mo 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.

10 ARTICLES

3mo ago

Kenvue Asks FDA to Reject Autism Warning on Tylenol in Pregnancy

4 ARTICLES

4mo ago

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

3 ARTICLES

4mo ago

FDA Regulations

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

Kenvue Asks FDA to Reject Autism Warning on Tylenol in Pregnancy

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

Cytokinetics Hit With Securities Class Action Over Aficamten Timeline Disclosures