While the complete response letter derails a near-term clearance, one analyst described the rejection as more of “a speed ...

Positive late-stage study results position the company to file for clearance of what could be the first narcolepsy drug that ...

The CDMO, which has been owned by different private investors over the last decade, will use the funds to broaden its geographic reach.

Baxdrostat, which AstraZeneca acquired in a 2023 buyout of CinCor Pharma, could become a new treatment for people whose hypertension is either uncontrolled by or resistant to existing medicines.

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

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

Some two dozen biotech developers of PROTACs, molecular glues and other types of protein-degrading drugs have sprung up over ...

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

Company executives had seen the drug as a potential multi-billion dollar opportunity in women’s health.

The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...