Depth-of-response measures, including MRD and symptom endpoints, reinforced broad clinical benefit beyond PFS, supporting consideration as a new second-line standard for eligible patients. Infection ...

However, President Trump posted on his Truth Social account this morning that he is “pleased to announce the new leadership ...

Lilly’s Foundayo is reportedly off to a strong start. The company’s obesity only recently hit the market, and a report from ...

FDA required additional post-approval evaluation of myocardial infarction, stroke, and other cardiovascular events because ...

In a conversation with Pharmaceutical Executive, Morten Graugaard, CEO, Orbis Medicines, discussed FDA’s approval of Icotyde ...

Behavioral data indicate substantial underuse: ~40% delay epinephrine and 56% of caregivers fear needle-based auto-injectors, ...

Model N’s Michael Grosberg breaks down the accelerated complexity, policy disruption, and data gaps testing manufacturer market access and revenue management strategies. In the debut episode ...

Formal triggers to reassess, restrict, or withdraw accelerated approvals are urged when postmarketing confirmatory trials lag ...

A reverse-merger structure uses Galera’s public listing and cash to bring Obsidian public, while Madan Jagasia is slated to ...

In today's Pharmaceutical Executive Daily, Eli Lilly releases updated safety data for its oral obesity pill Foundayo in ...

Marking a fundamental shift in how we define acceptable clinical proof, it has indicated that one well-controlled trial, ...

Replimune received a second FDA complete response letter for RP1 in advanced melanoma, raising questions about the viability of its oncolytic immunotherapy program. Replimune Group received a complete ...