FDA Delays Denali’s Hunter Syndrome Therapy Decision by Three Months

FDA delay; Denali Therapeutics; Hunter syndrome; tividenofusp alfa; MPS II; Biologics License Application (BLA); review extension; clinical pharmacology; major amendment; accelerated approval

Ypsomed Invests $248 Million to Establish First U.S. Manufacturing Site in North Carolina

Ypsomed; manufacturing expansion; U.S. facility; Holly Springs; North Carolina; CHF 200 million; self-injection systems; job creation; global growth strategy; medical technology