Food and Drug Administration (FDA)
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Eliem Therapeutics could be in trouble following the announcement that its drug candidate ETX-810, intended to treat diabetic peripheral neuropathic pain, did not meet its primary endpoint.
Patient deaths associated with Astellas Pharma’s gene therapy candidate underscore the risks of developing potential one-and-done treatment options for serious diseases.
Ardelyx announced the FDA’s OND, CDER, provided an interim response to the company’s second level of appeal for tenapanor. Here’s what you need to know.
Scientists from the U.K. may have identified several more environmental causes for cancer after evaluating genetic data of over 12,000 cancer patients from the NHS files.
Biogen has withdrawn its Marketing Authorization Application (MAA) for European approval of Aduhelm after regulators hinted data was not strong enough to support potential approval.
The WHO has indicated support for Pfizer’s Paxlovid and reversing a previous decision on using antiviral remdesivir, now recommending it in cases of mild to moderate COVID-19.
Toxicities and concerning patient survival data sparked a U.S. Food and Drug Administration advisory committee to recommend shutting the door on single-arm clinical studies of PI3K inhibitors.
The COVID-19 pandemic will end one day and, when it does, some biopharma companies will need to revert to a more normal way of working with others.
Thirty-five members of the Bloomberg New Economy International Cancer Coalition issued a call for a permanent change to the way cancer is diagnosed and treated around the world.
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