As the FDA prepares for a busy Oncologic Drugs Advisory Committee meeting next week, an agency insider told BioSpace that ...

FDA Commissioner Marty Makary was met with a skeptical set of Senate appropriators Thursday when he testified on his agency’s ...

While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner ...

The U.S. FDA approved Novavax's COVID-19 vaccine with conditions, allowing use for people 65 and older and those 12-64 with ...

The U.S. FDA has approved Novavax's COVID-19 vaccine, Nuvaxovid, for older adults and those aged 12 to 64 at risk of severe illness. Despite missed deadlines and regulatory challenges, the approval is ...

The US Food and Drug Administration (FDA) has approved Novavax's Covid-19 vaccine, Nuvaxovid, but only for limited use in ...

Novavax's full FDA approval for NUVAXOVID is a transformative milestone, unlocking a $175M Sanofi payment and validating ...

IntroductionThe global vaccines market has witnessed unprecedented growth in recent years, driven by technological ...

3SBio will receive an upfront payment of $1.25B and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to $4.8B as well as tiered ...

Novo Nordisk NVO announced the surprise resignation of its chief executive officer (CEO), Lars Fruergaard Jørgensen. Sanofi ...

In a landmark for U.S. public health digital transformation, the FDA said it will deploy generative AI enterprise-wide by the ...

While gaps persist in workforce retention, infrastructure, and equitable access, the transformation of Nigeria’s health ...