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The FDA issued a warning letter to Grimann, an over-the-counter (OTC) drug manufacturer located near Mexico City, for failure to comply with drug registration and listing requirements. Read More
Novartis confirmed Monday it was the victim of a cyberattack that ended in stolen data but maintained the hackers didn’t get away with any sensitive information. Read More
In a stunning mid-study analysis of 12 patients, GlaxoSmithKline’s anti-PD-1 antibody Jemperli (dostarlimab) completely eradicated locally advanced rectal tumors in every patient, sparing them life-altering surgery and causing minimal side effects. Read More
Breast cancer treatments by AstraZeneca (AZ)/Daiichi Sankyo and Gilead are grabbing headlines at the annual meeting of the American Society of Clinical Oncology this week. Read More
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