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Disclosure Requirements › Securities Litigation › Food and Drug Administration (FDA)

Sheppard Mullin Richter & Hampton LLP

Ninth Circuit Affirms Dismissal of Securities Fraud Suit: Marketing Slogan Alone Not Actionable Under Section 10(b) and Rule 10b-5

Sheppard Mullin Richter & Hampton LLP on

In Sneed v. Talphera, Inc., 2025 WL 2406424 (9th Cir. Aug. 20, 2025), the United States Court of Appeals for the Ninth Circuit affirmed the dismissal of a securities fraud suit against Talphera, Inc. (formerly AcelRx...more

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

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

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

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