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Court Rules for FDA in Vanda Label Case

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The DC District Court rules for FDA in a Vanda Pharmaceuticals lawsuit seeking an agency order to revoke the approval of a Teva AN...

More Accelerated Approval Changes Needed: Kaiser

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The Kaiser Permanente healthcare system calls for FDA and congressional changes to improve the utility of the drug accelerated app...

Astellas Wins Revised Label for Izervay

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FDA approves an Astellas Pharma supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) that revises the labeling ...

Petition Seeks FDA Leukeran Actions

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A Buchannan Ingersoll petition asks FDA to impose conditions on ANDAs for generic forms of the cancer drug Leukeran.

Endo Wants Generic Epinephrine Restrictions

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Endo asks FDA not to receive or approve any applications for a generic form of Endos epinephrine products that do not refer to the...

Vaccine Skeptic Kennedy Confirmed as HHS Secretary

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The U.S. Senate votes 52-48 to confirm vaccine skeptic Robert F. Kennedy Jr. to serve as the next HHS secretary.

Study Sees New Trazodone Adverse Events

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Researchers in China say they found several new adverse event signals in their review of 20 years of FDA adverse event reports on ...

DoJ Probing Inspire Marketing, Reimbursement

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The Department of Justice has requested information from Inspire Medical as part of a civil probe into its marketing, promotion, a...

FDA Clarifies Compounded GLP-1 Enforcement

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FDA clarifies its enforcement discretion timeframes for compounded tirzepatide.

Genentech Gets New Evrysdi Tablet Approval

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FDA approves a Genentech NDA for a new tablet formulation of Evrysdi (risdiplam) for treating people with spinal muscular atrophy.