The ODAC voted seven-to-one that data from the CAPItello-281 trial showed a favorable benefit-risk profile for Truqap plus abiraterone and ADT.

The firm said that after reviewing its oncology portfolio and seeing the PRMT5 inhibitor's initial activity, it decided to discontinue its development.

The firm reported an 8 percent increase in sales in the first quarter for its Keytruda family of products, which includes both Keytruda and the subcutaneous Keytruda Qlex.

The panel voted six to three that the available evidence doesn't support switching patients to AstraZeneca's camizestrant based on ESR1 mutations detected in circulating tumor DNA.

The firm posted $19.8 billion in total quarterly revenue, primarily driven by GLP-1 drugs but with contributions from ...

Kestrel has dosed the first patient in its Phase I trial evaluating KST-6051 in patients with advanced or metastatic solid tumors with KRAS mutations.

NEW YORK - The National MPS Society this week said it is awarding a $4 million grant to support a gene therapy program for mucopolysaccharidoses (MPS) IIIB (Sanfilippo syndrome type B) led by ...

The FDA has also granted bepirovirsen breakthrough therapy designation, building on a fast track designation from the agency in February 2024.

The firm is anticipating approvals in 2026 to push Enhertu into earlier breast cancer indications and Datroway into ...

The agency is slated to decide whether to grant accelerated approval to the drug for treating NSCLC patients with EGFR exon 20 insertion mutations by February 2027.

After the approval and rescinding of one company's designation, experts examine why sponsors might still leverage the program and what might give them pause.

Global sales of the anti-amyloid Alzheimer's drug, approved in 2023, grew 74 percent between Q1 2025 and 2026, reaching $168 ...