Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’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 ...

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 U.S. FDA on July 15 cleared Biocon Biologics Ltd.’s Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar product referencing Novo Nordisk A/S’ Novolog (insulin aspart), a ...

An FDA advisory committee ruled in two separate votes that two belantamab mafodotin combination regimens should not be used ...

Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...

In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...

This month in the Zantac litigation, the Delaware Supreme Court tossed all the plaintiffs’ experts in thousands of cases, ...

The FDA has accepted for review the sBLA to expand the indication of Arexvy (RSV vaccine, adjuvanted) to adults aged 18 to 49 years who are at increased risk.

Recent developments in the health sector highlight diverse changes from drug pricing initiatives by Bristol Myers and Pfizer ...

The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work ...