News
While GSK did not provide a specific reason for returning Wave Life Sciences’ WVE-006, the decision comes after the asset in September 2025 came below analyst expectations in a Phase Ib/IIa AATD study.
FEATURED STORIES
AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.
With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
THE LATEST
Earlier this year, the Centers for Medicare and Medicaid Services scrapped a previous proposal, from the Biden administration, to include anti-obesity medications in Medicare Part D coverage.
After decades of limited progress—owing to the difficulty of treating the disease and resultant market risk—glioblastoma research is entering a new phase spurred by smarter trials, targeted funding and renewed interest from companies like Merck and Jazz Pharmaceuticals.
A ripple effect of the NIH’s slashed 2026 budget will be felt throughout the biopharma ecosystem. Young companies must act now to weather the storm.
Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy families have turned to the news for answers. Meanwhile, the FDA insists it remains committed to notifying companies of any regulatory action before sharing information with the media or public.
Delays in the decision dates for high-dose Eylea are linked to issues at a Catalent-owned facility. Once these are resolved, Regeneron expects “to receive favorable action” on these applications, CEO Leonard Schleifer told investors.
A U.K. Court of Appeals ruling confirms the validity of a patent covering modifications of mRNA used in Moderna’s vaccines.
It’s not often that a CEO outright dismisses M&A prospects, but Moderna CEO Stéphane Bancel says the mRNA biotech has enough programs on its hands.
The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research into one entity.
In its first commercial quarter for ATTR-cardiomyopathy, Alnylam’s Amvuttra reached roughly 1,400 patients and made more than $490 million.
Merck has characterized its cost-cutting initiative as more of a reallocation of resources to support other, higher-growth areas of its business.