FDA winds down operations amid government shutdown
Though the FDA will continue its core activities, the agency will no longer be accepting NDAs and BLAs.
02 October 2025
02 October 2025
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.
The bioresearch centre expansion is part of AbbVie’s wider ploy to bolster its US operations.
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);
Pfizer becomes the first company to reach an agreement with the US government on MFN pricing.
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