The approval covers a first-line maintenance treatment for an aggressive form of small cell lung cancer, a historically difficult-to-treat disease.
The ongoing government shutdown has postponed the release of key economic data, leaving the Federal Reserve and investors in the dark.
The regulator's green light for Rhapsido, a first-in-class oral treatment for chronic hives, positions the company to challenge injectable rivals.
Gene therapy candidate TSHA-102 for Rett syndrome receives key designation, paving the way for an accelerated regulatory pathway.
The company outlined key milestones for its sublingual drug delivery platform, including a planned 2025 FDA submission for its high-dose aspirin.
Zepzelca combo becomes first approved maintenance treatment for extensive-stage small cell lung cancer, a historically difficult-to-treat disease.
The approval marks a new standard for first-line maintenance treatment in extensive-stage small cell lung cancer, a historically challenging disease.
Permanent J-Code from CMS aims to streamline reimbursement and broaden patient access for its graft-versus-host disease treatment.