Shots: Health Canada has authorized Hyrimoz on Nov 4, 2020 for marketing in Canada. Hyrimoz has been approved for use in all same indications as reference Humira, including rheumatology, gastroenterology […]readmore
Tags : Authorization
Shots: The companies collaborated to evaluate the usability of DNA Link’s AccuFind COVID-19 IgG antibody test in a healthcare setting The study intends to expand access to antibody testing outside […]readmore
COVID-19
Regulatory
Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a
Shots: The authorization is based on P-II BLAZE-1 study assessing the efficacy and safety of bamlanivimab (700/2800/7000 mg) alone or in combination with a second Ab vs PBO for the […]readmore
Shots: The Lucira’s COVID-19 all-in-one test kit test has been authorized for home use with self-collected nasal swab samples in individuals aged≥ 14yrs. who are suspected of COVID-19 by their […]readmore
Shots: Abbott has received the US FDA’s EUA for AdviseDx SARS-CoV-2 IgM lab-based serology test for use on the ARCHITECT and Alinity platforms Till now, Abbott has received EUA for […]readmore
Shots: The US FDA has granted de novo class II for cobas EBV test, providing HCPs a tool for monitoring transplant patients at risk for complications from infections or reactivations […]readmore
Shots: Sun Pharma has filed manufacturing and marketing authorization of Tildrakizumab to the PMDA for moderate-to-severe psoriasis and psoriatic arthritis in Japan Additionally, Sun Pharma has acquired Pola Pharma and […]readmore
Shots: Post FDA approval in 2017, Yescarta (axicabtagene ciloleucel) receives EU marketing approval for the treatment of Relapsed or Refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell […]readmore