Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

The Wegovy pill's approval signifies a shift from injectable to oral dosage forms, driven by patient preference for ...

“Powerful” new treatments for various types of cancer and neurodegenerative disorders, such as Alzheimer’s, Parkinson’s, and ALS, will likely get rolled out within the next few years, Food and Drug ...

ScinoPharm Taiwan (TWSE: 1789) today announced a landmark achievement in the global pharmaceutical landscape, securing U.S. Food and Drug Administration (FDA) approval for Glatiramer Acetate Injection ...

In coming weeks, Wegovy pill will be available in four doses: a starter dose of 1.5 mg, as well as 4 mg, 9 mg, and 25 mg. As ...

The FDA has approved Deseyne contact lenses with extended depth of focus for the correction of presbyopia, according to a ...