The vaccine space has been battered by strong headwinds in recent weeks, including high-level disruptions to FDA and CDC ...
A BioSpace analysis of all 80 priority review vouchers that have been handed out across the three FDA programs that offer ...
Acelyrin and Alumis plan to close their merger in the second quarter of 2025, pending clearances and shareholder approval.
At the heart of the deal is the drug candidate dordaviprone, which is months away from a regulatory verdict for its use in H3 ...
The last few years have been tough for the insulin market, with recent policies and high-level pressure forcing companies to ...
Konstantina Katcheves, Senior VP of Innovative Global Business Development at Teva Pharmaceuticals brings insights from the ...
Pfizer reacts to Donald Trump’s tariff threats on big pharma, another regulatory meeting is canceled under RFK Jr., AbbVie ...
Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its ...
Congress did not reauthorize the rare pediatric disease priority review program at the end of 2024. Advocates say the ripple effect is already being felt across biopharma.
The approval for the first-line treatment of esophageal squamous cell carcinoma comes shortly after a label expansion for the ...
The partners are pushing to expand Enhertu’s list of indications beyond its standing uses in breast, lung and gastric cancers ...
Less than two months after two FDA-related setbacks, Atara Biotherapeutics is again cutting its workforce in half. This time, ...
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