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While Moderna’s full-year sales landed in the upper end of its target range, Jefferies analysts said further reductions are needed if the biotech hopes to hit its 2028 break-even target.
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Heightened diligence standards and longer decision timelines for early-stage startups slowed venture activity last year, J.P. Morgan found in a report published ahead of the bank’s annual healthcare conference in San Francisco.
The prevalence of serious inflammatory safety issues such as cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome limits the reach of these transformative cancer therapies.
After greenlighting 56 novel therapeutics in 2025, four notable applications continue to await the agency’s action after being delayed from the fourth quarter last year.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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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.