Moderna will not commit to previous 2028 breakeven guidance as the ripple effects of the FDA’s refusal-to-file decision spread through its pipeline.

Following over a year of slow uptake, Vertex Pharmaceuticals and CRISPR Therapeutics expect Casgevy revenues to nearly triple ...

Eli Lilly has long been gearing up for the launch of orforglipron, announcing as early as February 2024 that it was ramping up manufacturing investments for the weight-loss pill.

Analysts are keeping a close eye on Vertex’s kidney disease portfolio, anchored by the IgAN drug povetacicept, as its nonopioid painkiller Journavx is poised for “incremental” growth in the first half ...

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 pushback builds against his decision to reject Moderna’s influenza vaccine ...

Moderna’s mRNA-1010 was expected to contribute $1 billion to the company’s coffers by 2028. That plan is now out the window after the FDA refused to even look at the application.

Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in ...

The sudden departure stands in contrast to other EU pharma leaders who have been given much longer transitions in recent months, including GSK’s Emma Walmsley and Novo Nordisk’s Lars Fruergaard ...

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 didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.

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