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

Coartem Baby, which was cleared by health authorities in Switzerland, will fill an important gap in treatment. Novartis plans ...

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

The cell therapy developer, which raised nearly $500 million in 2023 on the promise of its CAR-T work, has floundered since a ...

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

One analyst described Cogent’s data as a “home run scenario” for bezuclastinib, which the company is positioning as a ...

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

The antibody treatment could compete with Sanofi’s Dupixent and Eli Lilly’s Ebgylss, while offering the potential for less ...

The drugmaker will provide, at no profit, doses to treat up to 2 million people in resource-limited countries. Meanwhile, ...