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HUTCHMED and Innovent Biologics Report NMPA’s NDA Acceptance of Fruquintinib + Sintilimab for Renal Cell Carcinoma

Shots:China’s NMPA has accepted NDA of fruquintinib + sintilimab for the treatment of pts with locally advanced or metastatic renal cell carcinoma who have progressed on one tyrosine kinase inhibitor therapyNDA is backed by the P-II/III (FRUSICA-2) trial assessing fruquintinib + sintilimab vs axitinib/everolimus monotx. for 2L treatment of renal cell carcinoma pts…

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New Drug Designations - November 2023

New Drug Designations – November 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EMA and China. This month’s report includes 3 biological drugs, 12 small molecules, 13 cell and gene therapies, 1 peptide, 3 exosome-based therapy and 4 devices Atsena Therapeutics’ capsid AAV.SPR gene therapy, focused on the treatment of Leber congenital…

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Insights+ Key Biosimilars Events of August 2019

Insights+ Key Biosimilars Events of August 2019

Biosimilars are key alternatives for costly Biologics therapies and saving million dollars of patients in multiple diseases. Hence physicians are likely to adopt biosimilars a reference product to biologics possessing similar therapeutic properties in terms of potency, safety, and efficacy to original biologic products. Our team at PharmaShots has summarized key events of biosimilar space…

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