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The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
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The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
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, uniQure and many more.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
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Read our takes on the biggest stories happening in the industry.
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
As 2026 begins, a slate of high-stakes clinical readouts—from a pivotal study of Novartis’ cardiovascular candidate pelacarsen to a Phase III test of Eli Lilly’s next-gen Alzheimer’s drug—are poised to reshape therapeutic landscapes.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
While Novartis secured the biggest deal of the fourth quarter, a handful of riveting tales emerged from the bottom of the M&A list, including a zombie buyout and a bidding war. And no, we’re not talking about Metsera.
The major depressive disorder failure for BHV-7000 is the drug’s second, after Biohaven’s spinocerebellar ataxia treatment troriluzole was rejected by the FDA in November 2025.
With a pair of Phase III trial flops, Ultragenyx will explore cost reductions as analysts turn attention to an upcoming Angelman syndrome readout.
More than a dozen pharmas have recently struck deals with the White House to lower drug prices. Nevertheless, drugmakers reportedly plan to raise the U.S. prices of at least 350 branded medications.
Jefferies analysts envision a steady launch curve that could ultimately drive meaningful sales from people who are dissatisfied with existing treatments.
Both companies received agency requests for more evidence of the effectiveness of their therapies.
Four of this year’s biggest acquisitions topped 11-figure figures. One was 2025’s messiest bidding war.