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Pharmaceutical Industry › Securities Litigation › Disclosure Requirements

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Pivots on Publishing Complete Response Letters, Raising SEC Disclosure and Securities Litigation Implications

Skadden, Arps, Slate, Meagher & Flom LLP on

On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more

Snell & Wilmer

Securities Class Action Litigation Surges in Dollar Value Despite Steady Filing Numbers

Snell & Wilmer on

Cornerstone Research recently published its Securities Class Action Filings—2025 Mid-Year Assessment. The report contains useful data and information about the securities class action landscape thus far this year. The...more

King & Spalding

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

King & Spalding on

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

Hogan Lovells

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

Hogan Lovells on

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

WilmerHale

COVID-19 Lessons From Recent Securities Fraud Class Actions

WilmerHale on

In the wake of recent unexpected changes in the way that companies do business, the goods and services that consumers demand, and the accompanying market volatility, plaintiffs have begun filing securities fraud complaints...more

Cadwalader, Wickersham & Taft LLP

2016 Year In Review: Securities Litigation And Regulation

Cadwalader, Wickersham & Taft LLP on

2016 was an active year in securities litigation. In the first half of 2016 alone, plaintiffs filed 119 new federal class action securities cases. It was also a busy year for SEC enforcement proceedings, with a record 868...more

King & Spalding

Eleventh Circuit Confirms that Issuers are not Required to Disclose Retention of Outside Promotional Firms

King & Spalding on

On December 15, 2016, the United States Court of Appeals for the Eleventh Circuit affirmed the dismissal of a securities class action against Galectin Therapeutics Inc., a Georgia-based biotechnology company. The suit...more

Carlton Fields

Dismissal for Drugmaker Affirmed: Galectin Had No Duty to Disclose Payments to Promoters

Carlton Fields on

In re: Galectin Therapeutics, Inc. Securities Litigation, No. 16-10324, 2016 WL 7240146, ____ , F2d ___ (11th Cir. Dec. 15, 2016). The Eleventh Circuit recently addressed the circumstances under which a public company...more

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