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FDA testing aged raw cow’s milk cheese for bird flu
the FDA said the goal of testing will be two-fold: detecting the H5N1 virus and taking the necessary follow-up actions to protect consumers. Raw, unpasteurized milk is a known vector of bird flu ...
PharmExec10d
FDA’s New Accelerated Approval Draft Guidance
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...
pharmaphorum3d
FDA approves Adstiladrin as first gene therapy for NMIBC
The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring ... (cannot multiply in human cells) adenoviral vector-based gene therapy. Its safety and efficacy was evaluated ...
pharmaphorum2y
uniQure, CSL claim first okay for haemophilia B gene therapy
after the FDA cleared their Hemgenix therapy for adults with the bleeding disorder in the US. The adeno-associated virus (AAV) vector-based therapy is given as a one-shot intravenous infusion ...
Monthly Prescribing Reference25d
Gene Therapy Gets Priority Review for Recurrent Respiratory Papillomatosis
The Food and Drug Administration (FDA) has accepted for Priority Review ... PRGN-2012 is an adenovirus vector-based gene therapy expected to induce immune responses against HPV 6 or 11 infected ...