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January 24, 2024
Takeda has received FDA approval for HYQVIA, a subcutaneous immunoglobulin for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.
January 19, 2024
The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.
January 18, 2024
FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.
January 15, 2024
The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.
January 10, 2024
MHRA has granted a Clinical Trial Authorization to PharmaKure for its oral combined drug for the treatment of mild cognitive impairment.
December 21, 2023
The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.
December 14, 2023
RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.
November 30, 2023
Exagamglogene autotemcel seen as synechdoche.
November 13, 2023
Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.
October 20, 2023
The designation will grant Lisata EU marketing exclusivity for 10 years after approval and protocol assistance from EMA.