Hutchmed (HCM) announces that the supplemental new drug application for Orpathys has been granted approval by the China National Medical Products Administration, or NMPA, for the treatment of adult ...

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...

The list includes Novo Nordisk’s blockbuster diabetes injection Ozempic, weight loss shot Wegovy and diabetes pill Rybelsus, ...

The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.

In the final instalment of a written investigation to accompany our podcast Fractured, a mother faces life in an Auckland ...

The good news is that Investigational New Drug submissions and New Drug Applications continue to be above average, with the latter hitting a high not seen since 1999.

The first ever investigation of a sitting presidential suspect...It's a question, but it's page 200. Moon Ga-young and Choi ...

Santhera will launch its new drug for Duchenne muscular dystrophy in the UK within the next few weeks after getting the green light for NHS coverage.

To be clear, there will always be challenges in drug ... application of them, a more systematic approach to ECAs must be embedded into the overall development process. This can require new ...

The Europe and North America medical food markets are witnessing rapid growth driven by aging populations and rising chronic diseases. In Spain, dema ...

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