Drug Approval | October 18, 2021
U.S. FDA approves Roche’s Tecentriq as adjuvant treatment for small cell lung cancer
Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting
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
Conventional Itraconazole mainstay drug to fight fungal infection has high result variance and low patient compliance because of dosing dependence upon food, acidic beverage and antacid consumption
The company has enabled a transformation across three core areas with an investment target of US $ 150 million
The rolling submission to the U.S. FDA will begin in the fourth quarter of this year
The applicants will only have to get their Good Manufacturing Practices certification validated every five years to retain their licence
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