The FDA rebuked Baxter in a lengthy warning letter that outlined a series of production violations that led to a trio of ...

Delaying the use of subcutaneous Parkinson’s disease treatments by one year increases annual medical costs by 59.1%, ...

The PMCPA has ruled that Otsuka Europe’s involvement with a sponsored symposium | The PMCPA has ruled that Otsuka Europe’s involvement with a sponsored symposium webpage breached 11 clauses of the U.K ...

Many direct-to-patient (DTP) programs have significantly affected access to medicines, a survey of U.S. | Many direct-to-patient programs have significantly affected access to medicines, a survey of U ...

Alcon—the eye-focused pharma spun out of Novartis—is handing over $550 million to buy out Neurotech Pharmaceuticals, its ...

As policies from the last two presidential administrations put heightened focus on drug affordability in the United States, a ...

Recruiting an industry veteran to steer the company through its darkest hour of growth pressures, CSL has hired GSK’s Deborah ...

In its own approval announcement on Oct. 20, the FDA hailed Hibsago as a “first-of-its-kind” treatment in chronic hepatitis B ...

The FDA is codifying its regulations around mobile apps that go along with prescription drugs, offering a clearer framework ...

Ahead of a planned strike by the CDMO’s labor union later this month, Samsung Biologics has secured a Korean court ruling in its favor, shielding the bulk of its drug substance manufacturing from ...

Next-gen manufacturer Antheia is teaming up with the U.S. Department of War to build out its infrastructure and onshore the U.S. drug supply chain.  | The Department of War is allotting a conditional ...

Cosette Pharmaceuticals has achieved a corporate milestone, securing an FDA approval for a legacy Daiichi Sankyo drug in its ...