This is the third and final installment in a series examining the strategic implications of reported merger discussions ...

Krieger Scientific's Joseph Morwald explains how siloed departments, disconnected systems, and a lack of cross-functional accountability are creating the structural compliance gaps that FDA warning ...

Daniel Dornbusch (ddornbusch@mba2003.hbs.edu) leads the medical education team in Genentech?s Hematology Division. He previously worked for Genzyme, specializing in business, product, and corporate ...

FDA authorization covers adults ≥50, positioning mFLUSIVA as Moderna’s first mRNA influenza vaccine and expanding its US ...

A senior source close to the companies denied any active or historical basis for a transaction, and both firms declined to comment on the denial. Prior speculation centered on preliminary discussions ...

Pharmaceutical Executive spoke with Dr. Richard Graham, chairman and co-founder of TruTechnologies about FDA’s new program ...

It’s been an eventful week for pharmaceutical and biotech industries. Eli Lilly posted its strongest quarter ever. FDA ...

In July of this year, Krieger Scientific issued a release addressing the increase in 303 drug warning letters issued by FDA.

Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced that FDA granted approval of Simtriyo (centanafadine), a once-daily extended-release ...

FDA approved oveporexton for adult narcolepsy type 1, positioning orexin pathway restoration as a disease-focused approach versus traditional symptom-targeted regimens. As a selective OX2R agonist, ...

This past May, Pharmaceutical Executive reported that CVS Health decided to return Eli Lilly’s Zepbound to its list of ...

Rumored tie-up implies acquirer skepticism versus target premium, with AstraZeneca shares falling sharply while BMS rose, reflecting concerns about value transfer and integration risk. A major ...