Law ❯ Regulatory Compliance

FDA Regulations

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

Investor Class Actions Target Atara Over FDA Setbacks to EBVALLO

Filings focus on alleged nondisclosure of manufacturing lapses plus ALLELE trial flaws that undercut approval prospects.

GOP Senators Press FDA on Illegal Online Abortion Pill Sales, Launch Probe of Mifepristone Makers

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