The main patent for Ohtuvayre, the COPD drug at the heart of Verona’s $10 billion sale, expired in 2020. For Merck to make ...

The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.

Preliminary quarterly sales figures for Vykat surpassed Wall Street estimates, but shares fell on concerns the company may ...

The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA ...

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...