News
Vinay Prasad, the FDA’s Center for Biologics Evaluation and Research head, is accused of interpersonal impropriety as pushback builds against his decision to reject Moderna’s influenza vaccine candidate.
FEATURED STORIES
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
THE LATEST
AbbVie contends that Botox should have been excluded from the IRA drug price negotiation program because it is a plasma-derived product.
The oral version of Wegovy has made GLP-1 medicines more accessible and acceptable to many patients who had steered clear of injectable versions, healthcare analytics firm Truveta suggests.
A recurring theme Tuesday morning at Phacilitate’s Advanced Therapies Week was the quickly emerging potential of in vivo approaches to cell and gene therapy—a trend also reflected in recent investments by Eli Lilly and Regeneron.
The Taiwan-based company is establishing a manufacturing center for the U.S. market.
The pact between Madrigal Pharmaceuticals and Ruzhou Ribo Life Sciences could complement the former’s Rezdiffra, the first FDA-approved therapy for MASH. That drug made $287.3 million in the third quarter of 2025.
With 10 launches planned in the coming quarters, Gilead isn’t feeling the same acquisition urgency as its pharma peers—though the prospect of a takeover isn’t off the table.
The percentage of patients achieving total clearance of eczema lesions in a Phase 2b trial increased with prolonged rezpeg treatment.
After receiving a letter directly from CBER Director Vinay Prasad, Moderna said the FDA had previously signed off on the use of a licensed flu vaccine as a comparator for a Phase 3 study of mRNA-1010.
A lawsuit and FDA warning ensued after Hims & Hers launched a compounded version of Novo Nordisk’s new obesity pill, more Big Pharma report earnings—including from weight loss rivals Novo and Eli Lilly—and the gene therapy space sees another rejection.
Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.