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Food and Drug Administration (FDA) Shareholders Capital Markets

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

Paul Hastings LLP

Biotech Spin-Off Transactions

Paul Hastings LLP on

As we previously discussed (here and here), the biotech mergers and acquisitions market currently faces significant headwinds. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug...more

Skadden, Arps, Slate, Meagher & Flom LLP

Insights – June 2024

Explore the unique considerations for mergers and acquisitions in the AI sector, the return of IPOs, the implications of new Supreme Court decisions and other developments in this edition of Skadden’s quarterly Insights....more

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