Hot on the tail of AstraZeneca’s Imfinzi, Bristol Myers Squibb’s PD-1/L1 inhibitor Opdivo has expanded its non-small cell lung cancer (NSCLC) net with an ...

The approval was based on data from the randomized, double-blind, placebo-controlled, phase 3 CheckMate -77T trial.

The checkpoint inhibitor is now approved, based on CheckMate 77T findings, for neoadjuvant/adjuvant use in patients with resectable NSCLC.

The Food and Drug Administration has approved Opdivo before and after surgery for some with non-small cell lung cancer.

Bristol-Myers Squibb (BMY) wins FDA nod to expand the U.S. label for its blockbuster immunotherapy Opdivo in lung cancer.

The FDA has approved nivolumab plus chemotherapy as a neoadjuvant treatment for operable stage IIA to IIIB non–small cell ...

An expert explains study findings that associate a longer time until postsurgical melanoma recurrence with improved ...

Over the next three months, the agency could approve a rival to a fast-selling Pfizer heart drug, a much-debated lung cancer medicine and an addition to Vertex's dominant cystic fibrosis business.

Warren Buffett is famous for being a value investor while Peter Lynch tended to be growth-oriented. Some investors are ...

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.