News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Statutory Interpretation Life Sciences

Robins Kaplan LLP

Norwich Pharms., Inc. v. Kennedy Jr.

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: Salix holds NDAs for 200mg and 550mg Xifaxan. The 550mg strength product was approved to treat irritable bowel syndrome with diarrhea (“IBS-D indication”) and hepatic encephalopathy...more

Ropes & Gray LLP

Stem Cell Litigation Update: FDA Won the Latest Battle, but the Future of HCT/P Enforcement Remains Unclear

Ropes & Gray LLP on

On September 27, 2024, the U.S. Court of Appeals for the Ninth Circuit reversed the district court’s decision in U.S. v. California Stem Cell Treatment Center, Inc. (“California Stem Cell”), holding that a clinic’s stem cell...more

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