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

Moderna teams up with Recordati to commercialize rare disease therapy

iRegene’s Parkinson’s therapy gains FDA designation

The RMAT designation accelerates the development of regenerative medicine therapies for serious or life-threatening diseases

Brenig Therapeutics launches first-in-human trial of novel neurodegenerative therapy

The Phase 1 single and multiple ascending dose study is set to begin dosing in early Q1 2026

FDA go ahead for Eli Lilly’s therapy for hard-to-treat ovarian cancer

Sofetabart mipitecan is a novel folate receptor alpha (FR?) antibody-drug conjugate (ADC) leveraging proprietary linker technology and an exatecan payload to target tumor cells

Miach Orthopaedics’ BEAR implant gains FDA label claim for reduced arthritis risk

The BEAR Implant is the first sports medicine device to carry a label claim related to lowering PTOA risk

Lantern Pharma launches AI Center of Excellence in Bengaluru to scale precision drug discovery globally

Dr. Reddy's launches novel recombinant Hepatitis E vaccine ‘Hevaxin’ in India

It is currently the only vaccine authorized by the Drug Controller General of India (DCGI) for active immunization against HEV in adults aged 18 to 65

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