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Hernexeos is the second drug to secure an FDA approval under the agency’s priority voucher scheme, following in the footsteps of USAntibiotics’ Augmentin XR, which was granted the ticket in December 2025.
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After a rocky 2025, Sarepta Therapeutics’ executives admit they have work to do to bring patients back into the fold as sales of Duchenne muscular dystrophy gene therapy Elevidys continue to decline.
Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been implemented across all therapeutic areas before now.
Alternatives to opioids are desperately needed to better treat moderate to severe acute pain, but to date, we’ve seen few novel analgesics hit the market.
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Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
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After a strong open to the year, the public markets suffered a six-month drought that led to biotech’s tightest IPO window in years.
Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Industry leaders are focused on the resilience of key starting material supply and the knock-on effects of automation in the new year.
In a year that saw advisory committees placed under a particularly bright microscope at the FDA, the agency held fewer meetings than usual and agreed with its advisors only 57% of the time, Jefferies reported.
The fierce rivalry between Novo Nordisk and Eli Lilly is alive and well, as the two companies are expected to face off with their new obesity pills this year.
After getting the crucial first-mover advantage with an FDA approval for a weight loss pill, Novo Nordisk looks to win the market before rival Lilly can arrive with its own oral option for obesity.
J&J paid Numab Therapeutics $1.25 billion upfront for the asset in 2024 based on the belief that its dual mechanism of action could improve on existing therapies.
The Illinois-based pharma has committed more than $1 billion in milestones to secure rights to ZG006 and join a who’s who of drugmakers targeting the DLL3 protein.
One way Takeda lives out its values is by striving to ensure that patients are aware of and can access the company’s clinical trials. Two employees from its research and development organization discuss why representation matters and the work their team is doing to benefit patients now and in the future.
After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.