Top Regulatory News Stories – Week Ending June 1, 2018

On Monday BioMarin received FDA approval for Palynziq to treat a rare disease known as phenylketonuria. https://seekingalpha.com/article/4177692-biomarin-keeps-fda-approval-train-rolling On Wednesday the FDA approved TherapeuticsMD’s IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause.  This comes a year after the FDA issued a CRL rejection based[…]