Analysts questioned whether the complete response letter Replimune received was evidence of changing approval standards at ...

Medicine® is a pop-culture medical newsletter and exclusive benefit for 2 Minute Medicine Plus subscribers. Will Levis’s ...

Roche and Genentech were unable to sufficiently demonstrate the benefit of using Columvi in an earlier treatment setting for ...

Most Oncologic Drugs Advisory Committee members took issue with the lack of dosing optimization and the lack of US patient ...

Discover the latest breakthroughs in oncology, including pivotal FDA decisions, promising therapies, and new treatment options for multiple myeloma and ovarian cancer.

GSK plc has announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against ...

GSK was trying to revive a product pulled from US markets in 2022. Its shares fell 4.6 per cent, or 65p, to 1348p.

FRANKFURT: European shares were unchanged on Friday, as losses in heavyweight healthcare shares were countered by ...

The analyst further reasoned that the high ocular toxicity rates, including keratopathy and visual acuity changes, are ...

The FDA oncologic drugs advisory committee voted against the approval of GSK’s blood cancer treatment Blenrep, delivering a setback to the drugmaker’s efforts to reintroduce the drug to the U.S.

The FDA has declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL ...