Top Regulatory News Stories – Week Ending November 2, 2018

The US FDA has approved Novartis/Sandoz’s Hyrimoz, a biosimilar of Abbvie’s Humira, the world’s bestselling prescription medicine. TherapeuticsMD announced that the FDA has approved BIJUVA™ (estradiol and progesterone) capsules, 1 mg/100 mg, for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women.[…]