The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, ...

Vinay Prasad, the FDA's Center for Biologics Evaluation and Research head, is accused of interpersonal impropriety as ...

Moderna’s mRNA-1010 was expected to contribute $1 billion to the company’s coffers by 2028. That plan is now out the window ...

Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.

The sudden departure stands in contrast to other EU pharma leaders who have been given much longer transitions in recent ...

In this episode of Denatured, Jennifer C. Smith-Parker speaks with Dr. Rob Monroe and Jennifer Fakish at Danaher Corporation. They discuss how antibody drug conjugates (ADCs) are transforming cancer ...

An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it ...

AbbVie contends that Botox should have been excluded from the IRA drug price negotiation program because it is a ...

The oral version of Wegovy has made GLP-1 medicines more accessible and acceptable to many patients who had steered clear of injectable versions, healthcare analytics firm Truveta suggests.

Biopharma professionals need to understand today’s job market and how they can stand out to position themselves for success. Three talent acquisition and recruiting experts discussed these topics in a ...

The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two ...

The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.