Ultragenyx bags FDA priority review for groundbreaking GSDIa gene therapy

If approved, DTX401 would be the first treatment to address the disease at its root cause

Dr. Reddy’s secures first-mover advantage with FDA review of Orencia biosimilar

BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data

BioVersys’ novel TB drug shows promising results in Phase 2a Trial

The clinical program has benefited from extensive European Union support, including the IMI2 TRIC-TB and UNITE4TB projects, as well as funding from the EDCTP2 bEto-TB project

BMS reports positive Phase 2 data for Luspatercept in alpha-thalassemia

Both non-transfusion-dependent and transfusion dependent cohorts met their respective primary and secondary endpoints

Lilly’s Retevmo shows breakthrough results in early-stage lung cancer trial

The drug’s safety profile in LIBRETTO-432 aligned with previous selpercatinib studies, showing no unexpected concerns

FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer

The NDA filing is supported by results from the phase III evERA Breast Cancer study

FDA accepts Teva’s NDA for long-acting schizophrenia injection

If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations

Novartis bags Phase III win for Remibrutinib in chronic inducible urticaria

The results mark a potential breakthrough for patients living with CIndU, a condition with limited treatment options

Johnson & Johnson bags FDA nod for monthly RYBREVANT FASPRO dosing in advanced lung cancer

This approval builds on the recent transformation RYBREVANT FASPRO brought to lung cancer care

Asahi Kasei Pharma & Alchemedicine launch first human trials for hard-to-treat diseases drugs