We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Two years after its blood cancer treatment Blenrep (belantamab mafodotin) won accelerated approval from the FDA, GSK has removed the drug from the market in the U.S. at the FDA’s request. Read More
Complete document archives with self-explanatory file names are the top two — out of the top 10 — ways to be prepared for an FDA inspection, advised an FDA inspections expert at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More
In response to the nationwide shortage of the antibiotic amoxicillin, the FDA yesterday released guidance that allows compounders to produce beta-lactam antibiotic liquid suspensions to help satisfy the increased demand. Read More
In a win for Pfizer, the Patent Trial and Appeal Board (PTAB) has declared that EtranaDez (etranacogene dezaparvovec), CSL Behring’s investigational gene therapy developed by uniQure for hemophilia B, isn’t unique at all, but merely a tweak of Pfizer’s patented method to increase clotting factor IX with adenovirus-delivered genetic codes. Read More
Lysogene’s investigational gene therapy LYS-SAF302 preserved cognitive function and brain volume in a small set of infants with a devastating type of childhood dementia, mucopolysaccharidosis Type IIIA (MPS IIIA). Read More