Pfizer and BioNTech report positive data from an ongoing German Phase 1/2 trial involving its mRNA-based BNT162 coronavirus vaccine program.
FDA reissues an emergency use authorization to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for pooled Covid-19 specimen samples.
FDA posts a final guidance entitled Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 Public Health Emergency.
FDA Review posts summaries for medical product approvals for the week ending 7/17/2020.
Verathon recalls the GlideScope Core One TouchSmart Cable due to the potential for temporary or complete loss of image when used with certain video mo...
Federal Register notice: FDA announces an 8/18-19 Science Advisory Board to the National Center for Toxicological Research meeting.
Federal Register notice: FDA makes available a draft guidance entitled Use of Real-World Data and Real-World Evidence to Support Effectiveness of New ...
Federal Register notice: FDA announces it is revoking approval of an Eli Lilly BLA for Lartruvo (olaratumab), indicated for combination use with doxor...