Vera Pomerantseva, Director of Product Management for RBQM, eClinical Solutions, discusses FDA's shift to a single pivotal trial standard, in an effort to streamline drug development without lowering ...

Novo Nordisk issued a response to an FDA warning letter that cited serious violations in how the company tracked and reported ...

In 2025 it seemed the only certainty for biotech was more uncertainty. Biotech leaders conducted business as usual against ...

In today's Pharmaceutical Executive Daily, Senate Democrats press major pharmaceutical companies for transparency on the ...

In today’s Pharmaceutical Executive Daily, Vinay Prasad exits the FDA’s Center for Biologics Evaluation and Research for the ...

The second exit in under a year follows controversy around CRLs for Replimune and Capricor, including criticism that mid- and ...

In a conversation with Pharmaceutical Executive Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law ...

For Andrew Hall, a veteran of Big Pharma-turned biotech builder, he has spent much of his recent career operating inside those constraints — and learning how to lead through them. Today, as CEO of ...

A $400 million, four-year Blackstone Life Sciences financing supports ongoing and future duvakitug development, with ...

Testing identified significant impurity formation when tirzepatide is compounded with B12 variants, suggesting chemical incompatibility that is not evaluated under FDA review pathways. Uncertainty ...

Employer Connect aggregates diverse administrators, from basic benefits management to comprehensive obesity programs with wraparound services, enabling employers to tailor coverage models to workforce ...

In today’s Pharmaceutical Executive Daily, the FDA approves an expanded indication for Palynziq in patients aged 12 and older ...