Food and Drug Administration (FDA)
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Final analysis of the Himalaya trial demonstrated safety as well as a statistically relevant 22% improvement of overall survival (OS) without exposing the patient to an increase in liver toxicity.
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Biogen has withdrawn its Marketing Authorization Application (MAA) for European approval of Aduhelm after regulators hinted data was not strong enough to support potential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.
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