Search results
The US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) approved 15 new molecular entities and 6 new biologics in 2010. The total of 21 new products...
ABSTRACT: 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 categories.
11 mar 2021 · Abstract. 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 categories.
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...
1 mar 2011 · The US Food and Drug Administration approved a total of 53 new drugs in 2020, one of the highest numbers in the past decades, and shows that the trend for declines in drug discovery and development has clearly been broken.
1 lut 2011 · Several new medications are the first of their kind or serve a previously unmet need. Tocilizumab, or Actemra, was licensed in January and became the first new molecular entity or biologic approved in 2010.
1 lut 2011 · Drug approvals included new molecular entities, biologic license applications, as well as reformulations, combinations and new indication approvals.
