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 ...

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 ...

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

FDA authorized the first generic baloxavir marboxil, a cap-dependent endonuclease inhibitor, expanding single-dose influenza ...

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

Illinois, is backing legislation he says would lower prescription drug costs by targeting the use of Food and Drug ...

Ed Silverman formerly piloted The Wall Street Journal's Pharmalot blog tracking the pharmaceutical industry. His coverage included research and development, marketing, pricing, regulation, deals, ...