03 October 2025
03 October 2025
The approval was met with fury by right-wing groups while abortion rights supporters celebrated the news.
The pharma will step away from cell therapy in favour of biologics, small molecules and ADCs in a “strategic portfolio prioritisation”.
Amgen received a label expansion from the FDA in August 2025, with the VESALIUS-CV data supporting this decision.
Though the FDA will continue its core activities, the agency will no longer be accepting NDAs and BLAs.
Halozyme will expand its drug delivery offerings with a high-concentration biologics platform.
Though unexpected CRLs issued by the FDA have caused ripples in the industry, the agency's ex-chief counsel Becky Wood believes that these cases are the exception, not the rule.
Orphan drugs are therapeutics developed to address rare diseases typically defined by patient population thresholds that vary across regions: fewer than 20,000 patients in the US (FDA); no more than five in 10,000 in the EU (EMA) and the UK (Medicines and Healthcare Products Regulatory Agency (MHRA)), and fewer than 50,000 in Japan (National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN)).
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