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

Current operations chief Renee Gala will succeed Bruce Cozadd at Jazz. Meanwhile, a key study of an Ultragenyx and Mereo drug ...

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 biotech is taking inspiration from cystic fibrosis treatment and applying a similar approach to developing "corrector" ...

The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.

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

A slower ramp-up of Kisunla dosing lowers the rate of dangerous brain swelling, a risk that has made doctors reluctant to ...

The deal hands AbbVie a drug that’s shown early promise in multiple myeloma and may be useful treating other cancers and ...

The complaint argues Kennedy’s actions to remove the COVID vaccine from the CDC's immunization schedule for pregnant people ...

The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an ...