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

IT executive with extensive business leadership, service design & delivery, and operations skills across the NA, LATAM, and Eu ...

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

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

In an interview with Pharmaceutical Executive, Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, ...

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

Launch financing of $300M enables Beeline to operationalize an in-licensed immunology portfolio, with afimetoran (TLR7/8) in ...

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

A more dynamic, data-driven approach is redefining what “good” looks like in copay support.

Copay programs now directly influence access and manufacturer financial performance amid high deductibles, ...

Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, notes select ...

While FDA’s draft guidance may alleviate some of the pressures when biosimilar developers, there are still other significant ...