Shivam S
Shots:
The US FDA approved Tevimbra (tislelizumab-jsgr) + Pt containing CT as 1L treatment in unresectable or metastatic esophageal squamous cell carcinoma (ESCC) adults whose tumors express PD-L1 (≥1)
The approval was based on the P-III (RATIONALE-306) study (n=649) evaluating Tevimbra + CT vs. PBO + CT in unresectable, locally advanced recurrent, or metastatic…
Shots:
Dawn Health & Novartis have launched Cora BC app to offer support to all breast cancer pts & their kin following the development of Ekiva MS & Ekiva PNH. Launch will start in Germany, extending to other markets incl. UK, Canada & Australia
Cora BC tracks pts health with regular check-ins, intuitive graphs, plus personalized reminders…
Shots:
Xbrane Biopharma has resubmitted the BLA for its biosimilar of Genentech’s Lucentis (ranibizumab), to the US FDA post issuance of CRL in Apr 2024
The CRL stated requirement of additional information on the reference standard and follow-up actions from manufacturing site inspections. Xbrane has addressed the issues, qualifying new reference standard & completing…
The DIA India Medical Devices Conference 2020 is the first effort of DIA India to bring together leaders from the medical devices industry, regulatory and academia from India in New Delhi to discuss the current landscape and regulatory updates of the medical devices industry.
New upcoming medical devices regulations, changing landscapes and the evolution of…