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TLX66 was previously granted Orphan Drug status by the European Medicines Agency, but has not yet received a marketing authorization in Europe. Read More
The FDA has issued warning letters to two companies for making implied claims that their products could prevent or treat COVID-19, making them unapproved new drugs in the agency’s eyes. Read More
The first-line oral diabetes drug metformin has been linked to 40 percent higher risk of birth defects in the offspring of men who took it during the three months before conception. Read More
Sanofi and IGM Biosciences have signed an agreement to create, develop, manufacture and commercialize immunoglobulin M (IgM) antibody agonists against three oncology targets and three immunology/inflammation targets. Read More
The FDA has authorized second booster doses of the Pfizer and Moderna COVID-19 vaccines for adults aged 50 years and older and younger immunocompromised individuals. Read More
Amylyx’s amyotrophic lateral sclerosis candidate goes before the FDA today, the sole survivor in an investigational minefield that continues to explode clinical trials. Read More