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The FDA cited over-the-counter drugmaker Cosmax USA for violations at its Solon, Ohio facility, including training and quality control lapses. Read More
Health insurer Humana has filed a lawsuit against Teva Pharmaceuticals seeking to recover “substantial costs” it incurred in recalling and replacing the company’s heartburn drugs. Read More
The FDA expects sponsors of breast cancer trials to include men as well as women and the scarcity of men with the condition is not an acceptable reason for excluding them from a trial, according to a new final guidance from the FDA. Read More
Mexico’s drug regulators have approved RedHill Biopharma’s planned phase 2/3 trial of Yeliva (opaganib) in hospitalized COVID-19 patients with pneumonia. Read More
Vir Biotechnology plans to launch a phase 2/3 trial this month of VIR-7831, a neutralizing monoclonal antibody for the treatment of COVID-19 patients. Read More
Moderna has secured a $1.5 billion Operation Warp Speed contract to supply 100 million doses of a COVID-19 vaccine candidate to the U.S. government, with an option to supply 400 million more doses if needed. Read More