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

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

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

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 ...

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

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

The mRNA drug developer said it will begin discussing approval with the FDA, which has adopted stricter vaccine review ...