Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy

N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway

China nod to Darolutamide for metastatic hormone-sensitive prostate cancer

The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT

Lupin launches Dasatinib tablets in US, eyes $930 million oncology market

AbbVie’s Epcoritamab shows progression-free survival gain in relapsed/refractory DLBCL trial

Improvements were also seen in complete response rates, duration of response, and time to next treatment

Gradalis’ Vigil therapy dramatically extends survival in advanced ovarian cancer

The randomized, double-blind, placebo-controlled Phase 2b VITAL trial enrolled 91 patients with newly diagnosed Stage IIIb–IV epithelial ovarian cancer

Pfizer’s BRAFTOVI combo shows breakthrough results in aggressive colorectal cancer

The trial supports the potential for another chemotherapy backbone option that may be paired with encorafenib plus cetuximab in this patient population

Merck initiates phase 3 trial of calderasib with Keytruda QLEX for NSCLC

KRAS G12C-mutant advanced or metastatic nonsquamous non-small cell lung cancer

Shilpa Medicare aims for US approval of chemo nausea drug

Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections

BioInvent’s experimental combo shows promise in hard-to-treat ovarian cancer

Pembrolizumab has shown meaningful benefit only when combined with chemotherapy

RedHill Biopharma advances RHB-102 as once-daily oral therapy to combat GLP-1 side effects

The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation