Skip to content Skip to footer
Subscribe Now
News

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 therapy NDA 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…
June 5, 2025

Read more

New Drug Designations - November 2023
INSIGHTS+

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…
December 27, 2023

Read more

Insights+ Key Biosimilars Events of January 2020
INSIGHTS+

Insights+ Key Biosimilars Events of January 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilar is expanding its footprints worldwide with multiple collaborations. In Jan 2020, Pfizer launched its two biosimilars [Ruxience (biosimilar, rituximab) & Trazimera (biosimilar, trastuzumab)] at lowest WAC in the US Our team at PharmaShots has summarized key…
February 14, 2020

Read more

Insights+ Key Biosimilars Events of August 2019
INSIGHTS+

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…
September 9, 2019

Read more

Sign Up to Our Newsletter

Be the first to know the latest updates

[mc4wp_form id="13387" element_id="style-1"]