Ten years on from their approval, GlobalData reviews their market entry strategies, pricing dynamics over time, and ...

After hours of company pushback, FDA's Oncologic Drugs Advisory Committee voted that the benefit of immunotherapy in low or ...

September saw several notable 'firsts' in the regulatory landscape alongside the approval of four novel drugs in the U.S. Among ...

One upcoming decision—on a perioperative PD-1 regimen for lung cancer—comes as the FDA considers an overhaul of trial designs in this treatment setting.

Bristol-Myers Squibb's stock is set to rise with FDA approvals, acquisitions, and a strong oncology portfolio, despite ...

The agency is considering whether to limit the indications of Keytruda, Opdivo, and Tevimbra to PD-L1-positive patients amid testing uncertainties.

While it is highly effective in treating multiple types of cancer, its extremely high price has reignited the debate over how ...

An FDA expert panel on Thursday voted against a broader use of Merck (MRK) and Bristol-Myers (BMY) immune checkpoint inhibitors Keytruda and Opdivo. Read more here.

The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered.  | The days of broad stomach cancer labels ...

The ODAC will weigh risk-benefit analyses from the FDA and sponsors on Keytruda, Opdivo, and Tevimbra when given with chemo in all comers and in PD-L1-positive subgroups.

If approved, the potential restrictions would impact Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, which are marketed ...

Findings from the CheckMate 067 of patients with advanced melanoma include the longest follow-up of a checkpoint inhibitor in any tumor type.