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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…
16 hours ago

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Travere Therapeutics
NEWS

Travere Therapeutics Reports FDA Full Approval of Filspari for Proteinuria Reduction in FSGS

Shots: The US FDA has granted full approval to Filspari (sparsentan) to reduce proteinuria in pts (≥8yrs.) with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome Approval was based on the global P-III (DUPLEX) trial assessing Filspari vs irbesartan in 371 pts (8–75 yrs.) with biopsy-proven or genetic FSGS, following a 2wk. washout, with dose titration…
2 days ago

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NEWS

DualityBio Reports China NMPA Acceptance of BLA for Trastuzumab Pamirtecan in Metastatic HER2+ Breast Cancer

Shots: China’s National Medical Products Administration has accepted the BLA for DualityBio’s trastuzumab pamirtecan (T-Pam; DB-1303/BNT323), an investigational ADC, for the second-line treatment of unresectable or metastatic HER2+ breast cancer The application is supported by interim results from the pivotal P-III (DB-1303-O-3001) trial, which met its primary endpoint, demonstrating statistically significant improvement in PFS vs…
April 10, 2026

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NEWS

Sobi Reports Health Canada Approval of Empaveli for C3G and Primary IC-MPGN

Shots: Health Canada has approved Empaveli (pegcetacoplan) for patients (≥12yrs.) with C3 glomerulopathy (C3G) or primary IC-MPGN to reduce proteinuria, marking the first approved therapy for these indications in Canada Approval was based on the P-III (VALIANT) study, where Empaveli demonstrated a 68% reduction in proteinuria (uPCR), stabilization of kidney function, and clearance of C3…
April 10, 2026

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Sanofi
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Sanofi Reports Market Authorization for Nuvaxovid, Expanding COVID-19 Vaccine Options in Canada

Shots: Sanofi became the Nuvaxovid market authorization holder in Canada to supply the protein-based COVID-19 vaccine. Nuvaxovid to be available in Canada for the fall 2026-2027 season Authorization was supported by pivotal P-III trials demonstrating ~90% efficacy of Nuvaxovid in preventing symptomatic COVID-19. Demonstrated a favourable tolerability profile, supporting its use for seasonal vaccination Nuvaxovid…
April 9, 2026

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NEWS

Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC

Shots: The US FDA has received the NDA of neladalkib for the treatment of TKI pre-treated pts with advanced ALK-positive NSCLC NDA was supported by global P-I/II (ALKOVE-1) trial of neladalkib in TKI-pretreated advanced ALK-positive NSCLC, showing favorable activity incl. intracranial responses, targeting key progression drivers, & a generally well-tolerated safety profile; data to be…
April 8, 2026

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