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Trials of pulmonary/respiratory, neurology and rheumatology therapies have the lowest representation of African Americans and other ethnic minorities, while Hispanic/Latinx populations are the most underserved in pivotal oncology trials. Read More
The FDA has turned down a new drug application from Blueprint Medicines for Ayvakit (avapritinib) for treatment of adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST). Read More
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) called for new product information for hormone replacement therapy (HRT) to reflect the risk of breast cancer. Read More
A new study in France has found that hydroxychloroquine provides no benefit for COVID-19 patients, adding to the growing evidence that the anti-malaria drug has little value as a coronavirus treatment. Read More
President Trump on Friday outlined a strikingly ambitious plan to have a COVID-19 vaccine approved by the FDA and starting to be deployed by year’s end. Read More
Rick Bright, former director of HHS’s Biomedical Advanced Research and Development Authority (BARDA), told lawmakers in a hearing yesterday that the frequently cited 12- to 18-month timeline for developing a COVID-19 vaccine is unlikely to pan out. Read More