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

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, ...

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

The rumors of reported AstraZeneca–Bristol Myers merger discussions provide an opportunity to examine how multiple emerging capabilities may reshape corporate strategy, mergers and acquisitions, and ...

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 ...

A 51:49 CSPC-led joint venture will build and jointly operate a Shijiazhuang biologics drug-substance facility, targeting global supply and allowing scope expansion as production capacity and demand ...

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

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

Third-party data from distributors and vendors requires explicit controls for file receipt, validation, exception handling, ...

Recent changes at the U.S. Patent and Trademark Office are making it harder to challenge pharmaceutical patents, raising concerns that slower generic and biosimilar competition could undermine efforts ...

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