Search results
11 mar 2021 · A total of 378 novel drugs and 27 biosimilars approved by the U.S. Food and Drug Administration (FDA) between 2010 and 2019 were evaluated according to approval numbers by year, therapeutic areas, modalities, route of administration, first-in-class designation, approval times, and expedited review c ….
28 sty 2020 · There has been a steady rate of introduction of new drugs by CDER over the last two decades. Expedited approval of anticancer and biologics is seen as recent trend in drug development.
Regulatory Science (CIRS) annual analysis of New Active Substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the Japan Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA).
This Briefing presents the results from the Centre for Innovation in Regulatory Science (CIRS) annual analysis of New Active Substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), the Japan Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissm...
20 maj 2022 · Among the 206 novel drugs in tablet or capsule form approved by the FDA from 1995 to 2010, 81 (39.3%) were followed by an FDA-approved new formulation, and 167 (81.1%) had a generic version as of December 31, 2021.
9 lut 2024 · FDA New Drug Approvals by Type of Product, 1980–2022. Annual FDA approvals of new molecular entities, therapeutic biologics, and gene and cell therapies from 1980 to 2022.
28 kwi 2023 · Using a data set of drugs approved from 2010 to 2019 (before the COVID-19 pandemic), this analysis estimated the NIH investment in these drugs, including the cost of published basic and applied research associated with these products, cost of phased clinical trials of failed product candidates, and opportunity cost, using discount rates ...
