Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA ...

The potentially $4.4 billion deal is Madrigal’s second with a China-based biotech and hands the company six preclinical RNA ...

Shares of Evommune nearly doubled on data suggesting it has a potential threat to Dupixent. Elsewhere, a closely watched ...

Lyell’s trial will test its experimental cancer cell therapy directly against marketed counterparts. Elsewhere, Biogen swapped board chairs and venture firms are joining up at a “pivotal time” for ...

The mRNA specialist reiterated its financial estimates for 2026 amid a challenging U.S. regulatory environment where its influenza vaccine just hit a major setback.

Another FDA knockback for a gene therapy has investors and analysts redrawing expectations for the rare disease drug developer.

Sales of Casgevy, a gene-edited treatment developed with CRISPR Therapeutics, more than tripled compared to the third quarter ...

Lilly could pay Innovent Biologics up to $9 billion in a new alliance. Elsewhere, Roche tried to assuage investor concerns about its new multiple sclerosis drug and Roivant shares surged.

Shares fell as much as 6% in after-hours trading, a decline one analyst guessed may be because Yeztugo’s trajectory isn’t ...

The winners over the next five years” will be the companies that “fully integrate” artificial intelligence into drug ...

The FDA has lifted longstanding and the most severe warnings off of hormone replacement therapies for menopausal women.

The move drew skepticism from investors despite multiple recent research setbacks that have left questions about Sanofi’s ability to confront Dupixent’s looming patent expiration.