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The government resumed distributing the antibody combination earlier this month after pausing shipments over concerns about the treatment’s effectiveness against coronavirus variants. Read More
The FDA has granted accelerated approval to Takeda Pharmaceutical’s Exkivity (mobocertinib), the first oral tyrosine kinase inhibitor for nonsmall-cell lung cancer (NSCLC) associated with certain gene mutations that are detected using a proprietary gene-sequencing test. Read More
The EUA was originally granted in February but its distribution was restricted in late March due to concerns about an increase in variants of SARS-CoV-2 that are resistant to the drug. Read More
Based on follow-up talks with the agency, Roche has now decided to withdraw the drug’s indication, but says it will continue to evaluate Tecentriq as a treatment for TNBC. Read More
Roche has pulled its blockbuster cancer immunotherapy Tecentriq (atezolizumab) as a treatment for women with a form of triple-negative breast cancer (TNBC). Read More
Sesen Bio said it will not seek approval of Vysyneum in Europe “until there is more clarity from the FDA on the next steps in the United States.” Read More