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Nabriva Therapeutics drew a second complete response letter (CRL) from the FDA for its injected antibiotic Contepo (fosfomycin), but said the problem was not related to the drug’s safety or efficacy. Read More
Sanofi has progressed faster than anticipated with a COVID-19 vaccine candidate being developed in collaboration with GlaxoSmithKline (GSK), according to the company’s CEO. Read More
FibroGen has initiated a phase 2 trial of its monoclonal antibody pamrevlumab for the treatment of hospitalized patients with acute COVID-19 infections. Read More
Three high-ranking House Democrats have asked FDA Commissioner Stephen Hahn for more details of the agency’s review process for COVID-19 vaccines. Read More
FDA Commissioner Stephen Hahn assured House lawmakers yesterday that the agency will maintain its regulatory independence in reviewing COVID-19 vaccine candidates, staying at arm’s length from the Trump administration’s Operation Warp Speed, which aims to have an effective vaccine by year’s end. Read More
Canadian sterile drug manufacturer Viatrexx was hit with an FDA warning letter for serious violations of aseptic practices observed during an agency inspection. Read More