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The Supreme Court has agreed to hear a case centered on whether a 180-day notification is mandatory or optional — when the appropriate disclosures are made — before a biosimilar launch. Read More
Following tradition, FDA Commissioner Robert Califf will leave the agency on Inauguration Day, when Stephen Ostroff — deputy commissioner for foods and veterinary medicine — will temporarily assume the role. Read More
The FDA unlawfully delayed the admission of the drug thiopental sodium, a general anesthetic used to impose capital sentences through lethal injection, the Texas Department of Criminal Justice contends. Read More
In a loss for Sanofi and Regeneron, a federal judge upheld a jury verdict validating two of Amgen’s cholesterol drug patents for Repatha, denying a request to overturn the judgment and launch a new trial. Read More