FDA
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
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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.
The U.S. Food and Drug Administration (FDA) approved Gilead’s remdesivir under Emergency Use Authorization as a treatment for COVID-19 following reports the drug met its primary endpoint in a U.S. National Institute of Allergy and Infectious Diseases (NIAID) clinical trial.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 1, 2020.