The US Food and Drug Administration (FDA) has published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and drug-device ...

The US Food and Drug Administration (FDA) approved or tentatively approved 776 Abbreviated New Drug Applications (ANDAs) for generic drugs in 2021, continuing a steady decline in generic approvals in ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

Given the high stakes involved, the generic exclusivity period’s effects on competition should be scrutinized.

This Brush Up is sponsored by MilliporeSigma. Learn more about therapeutic synthesis pathways. Drug development is a process that spans many years, from the initial phase of identifying potential drug ...

Universities and hospitals are repurposing existing drugs through late-stage trials with funded costs up to 90% lower than ...

FDA authorized the first generic baloxavir marboxil, a cap-dependent endonuclease inhibitor, expanding single-dose influenza antiviral access and introducing a new competitor to the branded product ...

Universities and hospitals are repurposing existing drugs through late-stage trials with funded costs up to 90% lower than ...