Last edition
News about "New Drug Application "
Lynk Pharmaceuticals Secures NMPA NDA Acceptance for Zemprocitinib
Lynk Pharmaceuticals announces NMPA acceptance of Zemprocitinib NDA, backed by positive results from a phase-III randomised, double-blind, placebo-controlled clinical trial in China.
New Drug Application | 11/04/2026 | By News Bureau
Japan's MHLW accepts GSK's Bepirovisen for Review to Treat Chronic Hepatitis B
Japan’s health ministry has accepted GSK’s new drug application for investigational antisense therapy bepirovirsen, after Phase III trials showed significantly higher functional cure rates in chronic hepatitis B patients.
New Drug Application | 27/02/2026 | By News Bureau | 378
FDA Issues Complete Response Letter for Disc Medicine's Bitopertin in Rare Blood Disorder
US regulator seeks Phase III APOLLO trial results before approving bitopertin for erythropoietic protoporphyria, pushing potential decision until mid-2027.
New Drug Application | 19/02/2026 | By News Bureau | 103
Iberdomide, an investigational oral CELMoD therapy, is under FDA review in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma.
New Drug Application | 19/02/2026 | By News Bureau | 108
Daiichi Sankyo Submits sNDA in Japan for Datroway in First-Line Metastatic TNBC
Daiichi Sankyo files supplemental application in Japan for Datroway as a first-line treatment for metastatic triple negative breast cancer based on phase III trial data.
New Drug Application | 13/02/2026 | By News Bureau | 137
Takeda's Oveporexton NDA Accepted by US FDA with Priority Review for Narcolepsy Type 1
FDA grants Priority Review to Takeda’s investigational orexin receptor agonist oveporexton (TAK-861) for narcolepsy type 1, with a PDUFA decision expected in Q3 this year.
New Drug Application | 11/02/2026 | By News Bureau | 117
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 | 176
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 | 238
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 | 264
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy