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Publicly-Traded Companies Life Sciences Regulatory Oversight

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

Sheppard Mullin Richter & Hampton LLP

SEC Publishes Sample Letter to Companies on Environmental Disclosures

Environmental, social, and governance factors (“ESG”) have pushed to the forefront of the SEC’s attention in recent years. In September, building on prior guidance, the SEC’s Division of Corporate Finance released a sample...more

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