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 ...

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

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

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 ...

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, ...

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 ...

With the patent cliff looming, biosimilars can play an important role in the coming years. According to Newcomer, there are ...

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

While FDA’s draft guidance may alleviate some of the pressures when biosimilar developers, there are still other significant ...