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IP Australia issues Notice of Acceptance for FibroBiologics' fibroblast-PRP-nucleus pulposus disc regeneration method, weeks after a parallel European grant.
FDA's CBER issues compliance policy on donor blood pressure and pulse eligibility, with direct implications for Source Plasma collection and plasma-derived biologics supply chains.
FDA accepts Atara's tabelecleucel BLA resubmission as Class 2, setting a March 31, 2027 PDUFA date for the first potential U.S. allogeneic T-cell therapy approval.
FDA expands Anktiva's indication to high-grade papillary BCG-unresponsive NMIBC via efficacy extrapolation from CIS trial data.
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