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In this connection, the FDA approved the company’s investigational new drug (IND) application for HBM4003. The biopharma company said that the US clinical study follows an initial trial

PvP Biologics has been acquired following the conclusion of Phase 1 proof-of-mechanism study of investigational medicine TAK-062 (Kuma062), which is being developed to treat uncontrolled celiac disease. The

As per the supplemental New Drug Application (sNDA), the Japanese pharma company is seeking approval of ALUNBRIG for the first-line treatment of patients with anaplastic lymphoma kinase-positive (ALK+)

The approval for Trulicity in the new indication is for type 2 diabetes with established cardiovascular (CV) disease or multiple cardiovascular risk factors. The glucagon-like peptide 1 receptor

The breakthrough therapy status enables Padcev plus Keytruda combination to treat patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in

As per the new drug application (NDA) for lurbinectedin, which has been accepted for filing by the regulator, the two companies are seeking accelerated approval for its use

Keytruda plus chemotherapy achieved one of its dual primary endpoints of PFS in patients with mTNBC whose tumours expressed PD-L1. Keytruda, an anti-PD-1 therapy, works by blocking the

As per the new drug application (NDA) that has been accepted by the FDA, Novartis is seeking approval for the use of capmatinib as a treatment for first-line

Based on the result of the primary endpoint, Lilly has dropped its plan to pursue regulatory submission for solanezumab in people having dominantly inherited Alzheimer’s disease (DIAD) or