News & Analysis as of

Food and Drug Administration (FDA) Orphan Drugs Clinical Trials

Goodwin

Henlius Receives Orphan-Drug Designation for HLX22 (anti-HER2 mAb) for Gastric Cancer

Goodwin on

On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 binds to HER2 extracellular...more

King & Spalding

Not Quite the Titanic: The Food and Drug Omnibus Reform Act Rescues Some FDA Policy Initiatives

King & Spalding on

The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more

Goodwin

FDA Accepts Regeneron and Sanofi’s DUPIXENT (Dupilumab) sBLA for Priority Review

Goodwin on

Last week, Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted a Priority Review of the supplemental Biologics License Application (sBLA) for DUPIXENT (dupilumab) 300 mg weekly to treat patients...more

Knobbe Martens

China Drug Administration Proposes Pharmaceutical Data Protection Guidelines

Knobbe Martens on

On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from...more

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