The US Food and Drug Administration (FDA) has approved two Jazz Pharmaceuticals regimens containing Ziihera (zanidatamab-hrii) for the first-line treatment of adults with unresectable, locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastroesophageal adenocarcinoma (GEA).
Health Canada has approved the use of Bristol Myers Squibb Canada’s (BMS) Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for adults with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
Henlius has secured orphan drug designation (ODD) for its anti-HER2 monoclonal antibody, HLX22, from the European Commission (EC) for gastric cancer treatment.
The China National Medical Products Administration (NMPA) has granted approval to Astellas Pharma’s VYLOY (zolbetuximab), a first-in-class monoclonal antibody, for use in conjunction with chemotherapy for the first-line treatment of individuals with a specific type of gastric cancer.
The US Food and Drug Administration (FDA) has granted approval for BeiGene’s TEVIMBRA (tislelizumab-jsgr) for the treatment of adults with specific types of gastric cancer.
Signet Therapeutics has received approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for sigx1094, a potential treatment for diffuse gastric cancer (DGC).
Merck (known as MSD outside of the US and Canada) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for KEYTRUDA.
The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted breakthrough therapy designation (BTD) to Innovent Biologics’ olverembatinib for the treatment of succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumour (GIST).
Daiichi Sankyo and AstraZeneca’s ENHERTU (trastuzumab deruxtecan) has secured approval in the European Union (EU) as a monotherapy to treat adult patients with advanced HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received an earlier trastuzumab-based regimen.
Prestige BioPharma and Dr. Reddy’s Laboratories have signed a binding agreement to commercialise the former’s trastuzumab (HD201) biosimilar in select Latin America and Southeast Asian countries.
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