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Pfizer declined to comment on the precise timing of its submission to the FDA and said it can’t “speculate on how long the FDA’s review will take.” Read More
Tivdak must carry a boxed warning for ocular toxicity, as well as warnings for peripheral neuropathy, hemorrhage, pneumonitis and embryo-fetal toxicity. Read More
The FDA has approved Byooviz (ranibizumab-nuna), the first biosimilar to Roche’s blockbuster Lucentis (ranibizumab) for the treatment of several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss and blindness for older Americans. Read More
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