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After a 12-month period that saw the Belgian biotech consider a spinout, swap out CEOs, and enter a three-way acquisition agreement involving Ouro Medicines, Galapagos now has a new moniker.
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European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Jacobio discovered JAB-23E73, which is designed to treat several KRAS mutation subtypes, and is testing the therapy in multiple Phase I trials.
Stifel analysts said the label for cardiac myosin inhibitor Myqorzo is in line with their expectations and is differentiated compared with BMS’ Camzyos.
Pfizer and Metsera, Sarepta and uniQure made the list with dramatic tales. The other two spots went to the regulatory challenges facing biopharma under the new administration, especially in the vaccines sector.
The second half finished strong after two tumultuous years. What will 2026 bring for the biotech sector?
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
A report from analysts at Jefferies suggested that new screenings for metachromatic leukodystrophy and Duchenne muscular dystrophy could bump sales of the gene therapy Libmeldy by more than $100 million.
BioMarin Pharmaceutical has faced a rocky road, promising and then backing off revenue targets and cutting assets that have underperformed. But Amicus’ rare disease portfolio is already bringing in $600 million annually.
After 27 years in business, Cytokinetics hopes to pit its own cardiac myosin inhibitor against one it initially developed—now owned by Bristol Myers Squibb—in a market worth billions. Aficamten has a PDUFA date of Dec. 26.
Insmed pointed to a strong placebo response as the reason for the trial’s failure.
With zasocitinib, Takeda is looking to challenge Bristol Myers Squibb’s kinase inhibitor Sotyktu, for which the Japanese pharma is running a head-to-head study in plaque psoriasis. Takeda expects to file for zasocitinib’s FDA approval next year.