FDA
The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing facility.
FEATURED STORIES
After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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The new at-home saliva self-collection assay allows for broader screening than the standard and uncomfortable method using nose and throat swabs at a healthcare facility or testing location that requires a physical interaction with a healthcare professional.
Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here’s a look at what’s on the schedule for the next two weeks.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 8, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 7, 2020.
Developed by Novartis, the drug, Tabrecta, is designed for a type of NSCLC that has spread to other parts of the body and cannot be removed by surgery.
The drug can potentially reduce the risk of cardiovascular death and hospitalization for heart failure.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 6, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 5, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 4, 2020.
The U.S. Food and Drug Administration green-lit Roche’s new Elecsys Anti-SARS-CoV-2 antibody test that will help determine whether or not people have been infected by the novel coronavirus and developed antibodies to the disease.