In July of this year, Krieger Scientific issued a release addressing the increase in 303 drug warning letters issued by FDA. In 2025, as new leadership took over the agency, FDA sent 303 drug warning ...
Commercial Evidence aggregates compliant signals from in-person and digital engagement to reveal “why/why not” drivers of ...
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 ...
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 ...
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 authorization covers adults ≥50, positioning mFLUSIVA as Moderna’s first mRNA influenza vaccine and expanding its US ...
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 ...
This past May, Pharmaceutical Executive reported that CVS Health decided to return Eli Lilly’s Zepbound to its list of ...
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 ...
This is the third and final installment in a series examining the strategic implications of reported merger discussions ...
Sandoz Inc. and Fougera Pharmaceuticals will settle three Connecticut federal cases, paying $400 million over seven years plus ~$50 million to prior settlors, pending approvals from all participating ...