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News about "New Drug Application "
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
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 | 104
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 | 136
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 | 234
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 | 611
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 | 496
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 | 453
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