Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
Ivenix selected Tritan MXF for the pump exterior because of its excellent chemical resistance and durability in the face of the aggressive disinfection protocols needed to prevent the spread of healthcare-associated infections
Second interchangeable biosimilar product approved by agency
The WHO chief scientist Soumya Swaminathan tweeted on Oct. 17
Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting
The trial met the primary endpoint of overall survival with a single priming dose of tremelimumab plus Imfinzi every four weeks vs. sorafenib
The interim analysis showed that the MVC-COV1901 vaccine has a good safety profile and elicits promising neutralising antibody titres
U.S. FDA has accepted the investigational new drug application for phase 1 clinical trial in non-Hodgkin’s lymphoma
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It works by collecting aerosols and identifies the presence of dangerous pathogens using sensitive, specific and rapid detection in near-real time without laboratory analysis
The company’s pharmaceutical API products Ibuprofen and fenofibrate got the go-ahead
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