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.

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 in 2026, as patient access to the sickle cell disease and beta thalassemia ...

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, ...

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

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

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 ...

Last month, biopharmas let go or projected they would let go of less than 500 people combined, based on BioSpace estimates, down almost 1,000 from January 2025. Still, competition for open jobs ...

A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company ...

Taiwan’s PharmaEssentia has committed $46 million to build a Puerto Rico drug manufacturing facility to serve the U.S. market ...

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 ...