Type-3 New Drug Applications, focusing on new dosage forms, dominate the 505(b)(2) pathway approvals, with injectable formulations being the largest category. Stability and manufacturing consistency ...

The FDA has updated its draft guidance on bioequivalence studies with fresh advice for developers of drugs in a range of dosage forms. Publication of the updated draft comes almost eight years after ...

In the evolving landscape of pharmaceutical development, modified release (MR) tablets have emerged as a cornerstone technology for improving therapeutic outcomes and patient compliance. Unlike ...

"New drug form may help treat osteoporosis, calcium-related disorders." ScienceDaily. www.sciencedaily.com / releases / 2021 / 01 / 210106082807.htm (accessed February 8, 2026).

Acetaminophen is a generic drug that’s taken for pain relief and fever reduction in adults and some children. Acetaminophen comes in several dosage forms. The dosage can vary depending on what ...