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 ...

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 ...

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 ...

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

The success of Vertex's opioid alternative Journavx could aid a group of biotechs that aim to take a similar path with NaV1.8 ...