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In a March 30 meeting, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 6-4 against recommending AMX0035 for patients with ALS. Read More
Novavax goes before FDA’s Vaccines and Related Biologics Advisory Committee this week, seeking Emergency Use Authorization of its COVID-19 vaccine. Read More
Johnson & Johnson’s (J&J) and AbbVie’s blockbuster cancer drug Imbruvica (ibrutinib) plus chemotherapy significantly slashed cancer spread in older patients suffering from mantle cell lymphoma (MCL) in a phase 3 study. Read More
Bristol Myers Squibb’s Orencia (abatacept) and Janssen’s Remicade (infliximab) reduced the risk of death among patients hospitalized with COVID-19 by around 40 percent, according to a study commissioned by the National Institutes of Health. Read More
The company will continue to work with the FDA to complete the review of the BLA and will be “ready to launch upon approval,” said TG Therapeutics CEO Michael S. Weiss. Read More
The companies said they are “assessing the FDA’s comments” in the Complete Response Letter and considering what they will need to gain approval for the indication. Read More
Pfizer and BioNTech hit back against Alnylam Pharmaceuticals’ claims alleging their COVID-19 vaccine infringed on Alnylam’s patent for lipid-nanoparticle delivery (LNP) technology. Read More