Alexandra Lu

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Latest Posts › Food and Drug Administration (FDA)

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FDA Approves Amgen’s WEZLANA As Biosimilar to and Interchangeable With Janssen’s STELARA (ustekinumab)

On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA....more

11/6/2023 / Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Contract Negotiations , Drug Pricing , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

Recent FDA Initiatives to Support Development of Individualized Cell and Gene Therapies and Rare Disease Therapies

Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the...more

10/19/2023 / Biopharmaceutical , Biotechnology , Food and Drug Administration (FDA) , Genetic Materials , Life Sciences , Therapeutic Services

Order in Amgen v. Sandoz Provides First Judicial Interpretations of the BPCIA Patent Dispute Resolution Provisions

On March 19, 2015, the District Court for Northern District of California (Judge Seeborg), issued an order providing one of the first judicial interpretations of the patent dispute resolution provisions laid out in subsection...more

3/20/2015 / Amgen , Biologics , BPCIA , Dispute Resolution , Food and Drug Administration (FDA) , Patents , Preliminary Injunctions , Sandoz v Amgen

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