News
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.
FEATURED STORIES
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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
AstraZeneca joins Johnson & Johnson and Bristol Myers Squibb in appealing a previous legal loss for its challenge to the government’s drug price-setting program.
Citing the need for another human factor study and more technical data for the final product, the FDA denied approval of Orexo’s nasal spray rescue medication for opioid overdose.
Pfizer selects its candidate for the oral GLP-1 race as Eli Lilly strives to overtake Novo Nordisk in the injectable weight-loss drug space. Meanwhile, pressure builds to reduce drug prices in the U.S.
Restructuring can invite lawsuits if companies aren’t careful. Following local, state and federal rules is critical, as is keeping the employee handbook current.
This week, Carina discusses how to transition into a career in biotech when you don’t have lab experience. Plus, handling difficult interviews and getting a “dry” promotion.
Backed by Bain Capital, Cardurion Pharmaceuticals will use the Series B funds to advance two assets for heart failure and other cardiovascular conditions.
Asceneuron, which develops small molecules targeting tau protein aggregation, plans to use the funds to advance its Alzheimer’s disease asset into Phase II.
To help keep pace with the demand for GLP-1 therapies, CordenPharma has announced a sizeable $980 million investment in its U.S. and European sites.
To improve its reviewers’ understanding of cell and gene therapy manufacturing, the agency has launched a program that will involve a tour of manufacturing facilities and daily workshops for its staffers.
After discontinuing its long-acting insulin product Levemir, Novo has again found itself under legislative scrutiny, with three Democratic senators seeking a sit-down with the pharma.