Selkirk Pharma, Inc., a privately held U.S. pharmaceutical manufacturer specializing in the fill and finish of injectable drugs, including vaccines and biological therapeutics, today announced the Aseptic Process Simulation (APS) qualification of its sterile manufacturing facility and newly available fill/finish capacity.
FDA’s CBER chief hints at expanding Sarepta’s gene therapy label, sends stock up 25%
Despite a failed confirmatory trial announced in October, the FDA’s Peter Marks, the top regulator for all cell and gene therapies in the US, is