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The FDA has approved Ferring Pharmaceuticals’ fecal transplant therapy Rebyota for the prevention of recurrence of C. difficile infection (CDI) in individuals that have completed antibiotic treatment for recurrent CDI. Read More
Spectrum Pharmaceuticals, receiving yet another blow from the FDA on its cancer therapy candidate, poziotinib, has announced that it will drop its poziotinib program and is laying off 75 percent of its research and development staff. Read More
CSL Behring has won FDA approval for Hemgenix (etranacogene dezaparvovec-drlb), a gene therapy with the potential to cure hemophilia B and — at $3.5 million per treatment — the most expensive drug in the world. Read More
The FDA is proposing to add arginine hydrochloride (HCl) and lysine HCl to its 503B Bulks List of active pharmaceutical ingredients approved for compounding. Read More