FDA reviewers argued RECIST v1.1 response and DoR may be inflated because injected-lesion shrinkage could represent local ...

Executive vice president and chief digital officer at Sanofi. Prior to being appointed chief digital officer, he held the positions of global head, digital GBU teams and digital products. He also has ...

Formulary decisions commonly restrict access to T2D and weight loss, creating coverage blind spots as GLP-1 trials mature across broader cardiometabolic and organ-protection indications. Utilization ...

Earlier this year, a report from Pharmaceutical Executive detailed the ways in which China is becoming an essential R&D partner for pharma and biotech companies. According to the ...

This episode of The Ron Lanton Report examines why the next phase of healthcare innovation will be constrained not by capital or technology, but by people. Framing the discussion ...

FDA approval used the 505(b)(2) pathway and Phase III Luminous results to support efficacy, safety characterization, and adhesive performance in women with BMI <30 kg/m². Contraceptive efficacy in the ...

Jay Bregman, CEO and co-founder of Andel, discusses how FDA’s action signals a broader regulatory recalibration aimed at protecting intellectual property and explores the second-order effects. Jay ...

Bansi Nagji discusses the shifting science behind rare and orphan drug development, including what it takes for therapies to succeed well beyond launch.

Within your prior big pharma employers, AI is now a core competitive capability as it has shortened target identification and optimized molecule design. As building world-class AI drug-discovery ...

A SPAC deal with RA Capital–sponsored RACC is expected to yield ~$175 million gross, including a fully backstopped trust and PIPE/SAFE financing, with closing targeted by end of 2026. Rugonersen, an ...

Project Trialblazer prioritizes reducing IND review timelines, but its impact on sponsor behavior may be limited when ...

Since then, that mindset has continued to grow at AbbVie.