Analysts do not believe the Phase III stumble for aticaprant will derail J&J’s broader neuroscience strategy, particularly ...

Despite comments made by a Novo Nordisk official this week, the company confirmed to BioSpace that it has no additional ...

Imfinzi is one of AstraZeneca’s key growth drivers for 2025, with potential approvals in stomach and bladder cancers. The ...

Analysts at Jefferies see Makary as a positive for the rare disease space, given his support for accelerated approvals and ...

Days after suffering a rejection in Australia, the Alzheimer’s drug hit another roadblock in the U.K., which found the drug ...

While Congress is renewing the priority review voucher program for rare pediatric diseases, the FDA should be required to ...

Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its ...

Novo Nordisk is intervening in the lawsuit filed by a drug compounders trade group against the FDA over the agency’s decision ...

Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to ...

Neffy 1 mg is the “first significant innovation” for epinephrine delivery in small children aged 4 years and up in over 35 ...

The approval for the first-line treatment of esophageal squamous cell carcinoma comes shortly after a label expansion for the ...

Congress did not reauthorize the rare pediatric disease priority review program at the end of 2024. Advocates say the ripple ...