The label expansion sought by GSK is a bid to compete with Pfizer and Moderna in the younger age groups of the RSV vaccine market. Pfizer’s Abrysvo and Moderna’s mRESVIA are both approved to prevent ...

Ultragenyx Pharmaceutical has received a complete response letter (CRL) from the FDA concerning its BLA for UX111 (ABO-102).

With clinical trials under pressure, industry leaders say it’s time for reform, digital transformation, and more patient-centric models.

The FDA has accepted MSD’s doravirine/islatravir new drug application (NDA) for review to treat adults with virologically suppressed HIV-1.