Partner Therapeutics Reports the US FDA sBLA Submission of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma

Shots: The US FDA has received the sBLA of Bizengri (zenocutuzumab-zbco) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion sBLA was supported by eNRGy study assessing Bizengri in pts with NRG1 fusion-positive cancers, incl. cholangiocarcinoma, showing an ORR of 36.8% & mDOR of 12.9mos. per BICR, in…

ByRidhi RastogiApril 15, 2026

NEWS

Cleveland Diagnostics’ IsoPSA Test Receives the US FDA Premarket Authorization for Prostate Cancer Diagnosis

Shots: The US FDA has granted a PMA to the IsoPSA in vitro diagnostic (IVD) kit for the diagnosis of high-grade prostate cancer Approval was based on the clinical evidence from a prospective study of the IsoPSA test conducted at 14 sites across the US, as well as data from supporting analytical validation studies IsoPSA, a…

ByRidhi RastogiDecember 1, 2025

NEWS

Exelixis Reports the US FDA’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Shots: The US FDA has approved Cabometyx for treatment-experienced, inoperable, LA/M, well-differentiated pancreatic NET (pNET) & extra-pancreatic NET (epNET) pts (≥12yrs.) Approval was based on P-III (CABINET) study assessing Cabometyx (60mg) vs PBO among 298 US pts (2 arms: pNET: n=99; epNET: n=199) that showed improved PFS; data was presented at ESMO 2024 & published…

ByRidhi RastogiMarch 27, 2025

INSIGHTS+

Insights+ Key Biosimilars Events of March 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of March, Samsung Bioepis Initiated P-I Study of SB17…

BySenior EditorApril 1, 2021

INSIGHTS+

Insights+ Key Biosimilars Events of July 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Cadila expanded its footprints in India with the launch of its two biosimilars Bevaro (bevacizumab, biosimilar) and Ritucad (rituximab, biosimilar) Our team at PharmaShots has summarized 9 key events of the biosimilar space of July 2020 1. Samsung…

BySenior EditorAugust 7, 2020

Partner Therapeutics Reports the US FDA sBLA Submission of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma

Cleveland Diagnostics’ IsoPSA Test Receives the US FDA Premarket Authorization for Prostate Cancer Diagnosis

Exelixis Reports the US FDA’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Insights+ Key Biosimilars Events of March 2021

Insights+ Key Biosimilars Events of July 2020

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