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, ...

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

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

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

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

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

The oral version of Wegovy has made GLP-1 medicines more accessible and acceptable to many patients who had steered clear of ...

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

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.

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 ...

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 agency flagged several violations at a compounding pharmacy owned by Hims & Hers, including “infestation by rodents, ...