News about "New Drug Application "

HUTCHMED Gets Priority Review in China for Fanregratinib NDA

HUTCHMED’s NDA for fanregratinib in second-line intrahepatic cholangiocarcinoma has been accepted in China with priority review status, supported by data from a phase II registration trial addressing a high-unmet-need liver cancer indication.

New Drug Application | 02/01/2026 | By News Bureau

Cogent Biosciences Submits NDA for Bezuclastinib in Non Advanced Systemic Mastocytosis

Cogent Biosciences has submitted a New Drug Application to the US FDA for bezuclastinib in non-advanced systemic mastocytosis, supported by positive results from the SUMMIT pivotal trial and following its Breakthrough Therapy Designation for patients with smouldering systemic mastocytosis and previously treated NonAdvSM.

New Drug Application | 31/12/2025 | By News Bureau |  148

Innovent TABOSUN Becomes China's First Approved Domestic Anti CTLA 4 Antibody

Innovent Biologics has received approval from China’s National Medical Products Administration (NMPA) for TABOSUN (Ipilimumab N01 Injection), marking the country’s first domestically developed anti-CTLA-4 monoclonal antibody and a significant milestone in China’s immuno-oncology landscape.

New Drug Application | 26/12/2025 | By News Bureau |  143

Anbenitamab Set to Lead as First Bispecific mAb in China's HER2+ Gastric Cancer Market: GlobalData

China’s NMPA has accepted Alphamab Oncology’s NDA for KN026 (Anbenitamab), which could become the first bispecific mAb for HER2-positive gastric and GEJ cancer, according to GlobalData.

New Drug Application | 25/09/2025 | By Dineshwori |  209

Johnson & Johnson Secures US FDA Priority Review for TAR-200 NDA

Johnson & Johnson has announced that the US FDA has granted Priority Review to its New Drug Application for TAR-200, a first-of-its-kind intravesical gemcitabine-releasing system, for treating BCG-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ.

New Drug Application | 18/07/2025 | By Mrinmoy Dey |  125

Bayer Seeks US FDA Approval of gadoquatrane for MRI of CNS and Other Body Parts

Bayer has submitted a New Drug Application to the US FDA for gadoquatrane, an investigational MRI contrast agent. If approved, it would offer the lowest gadolinium dose among macrocyclic GBCAs in the US, cutting exposure by 60 percent while maintaining diagnostic efficacy.

New Drug Application | 18/06/2025 | By Abha |  183

PTC Therapeutics Submits NDA for Vatiquinone to FDA

The vatiquinone NDA is based on data from the placebo-controlled MOVE-FA study as well as results from two long-term studies including pediatric and adult FA patients.

New Drug Application | 24/12/2024 | By Aishwarya |  299

Ionis Receives FDA Approval of New Drug Application for Donidalorsen

Donidalorsen is designed to reduce the production of prekallikrein (PKK), interrupting the pathway that leads to HAE attacks.

New Drug Application | 06/11/2024 | By Aishwarya |  796

Antengene Receives Approval for XPOVIO for Commercialisation in Thailand

This successful approval for XPOVIO in Thailand will introduce novel therapies to the clinical management of patients with MM in Thailand, benefiting many patients and their families in the country.

New Drug Application | 24/09/2024 | By Aishwarya |  566

Antengene Gets Malaysian Regulatory Agency Approval for XPOVIO Commercialization

Antengene has announced that Malaysian National Pharmaceutical Regulatory Agency has approved a New Drug Application (NDA) for XPOVIO (selinexor).

New Drug Application | 06/08/2024 | By Aishwarya |  507