Securities Litigation, Investors, Food and Drug Administration (FDA)

FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come

King & Spalding on 7/14/2025

On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more

FDA’s creation of public database of 200 Complete Response letters raises questions

Hogan Lovells on 7/11/2025

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

Second Circuit Highlights Difficulty in Pleading Fraud Claims Involving the Interpretation of Clinical Data

Cooley LLP on 1/31/2024

Plaintiffs often file securities fraud claims against pharmaceutical companies alleging that the company misled investors about clinical data, despite the US Food and Drug Administration (FDA) subsequently approving the drug...more

California Federal Court Denies Motion to Dismiss Securities Class Action Arising from Uber’s IPO

Goodwin on 8/27/2020

California Federal Court Denies Motion to Dismiss Securities Class Action Arising from Uber’s IPO; S.D.N.Y. Dismisses Ponzi Scheme Action Against HSBC Hong Kong for Lack of Personal Jurisdiction; Delaware Court of Chancery...more

Second Circuit Narrowly Applies Supreme Court’s Decision in Omnicare

Sheppard Mullin Richter & Hampton LLP on 4/5/2016

In In re Sanofi Securities Litigation, No. 15-588-cv, 2016 U.S. App. LEXIS 4107 (2d Cir. Mar. 4, 2016), the United States Court of Appeals for the Second Circuit affirmed the dismissal of class action complaints alleging that...more

Securities Litigation › Investors › Food and Drug Administration (FDA)

FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come

FDA’s creation of public database of 200 Complete Response letters raises questions

Second Circuit Highlights Difficulty in Pleading Fraud Claims Involving the Interpretation of Clinical Data

California Federal Court Denies Motion to Dismiss Securities Class Action Arising from Uber’s IPO

Second Circuit Narrowly Applies Supreme Court’s Decision in Omnicare

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