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 ...

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 ...

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

FDA now permits Arexvy for adults 18–49 with elevated RSV risk from conditions such as chronic cardiopulmonary or renal disease, obesity, and diabetes. Epidemiology in U.S. adults 18–49 includes ...

Poor/fair health status correlated with greater cost-related trade-offs, indicating those with higher healthcare utilization are simultaneously more exposed to affordability-driven nonadherence and ...

In today's Pharmaceutical Executive Daily, a new West Health-Gallup survey finds that more than 82 million Americans have cut back on daily expenses to cover healthcare costs, the FDA expands the ...