Search results for " drug approval"
Article
Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
Article
Trends in BioPharma Approvals in 2013
Download the table of 2013 drug approvals.
References
1.G. Walsh, Biopharm Int. 26 (4) 54-56 (2013).
2.G. Walsh, Biopharm Int.25 (6), 34-36 (2012).
3.G. Walsh,Biopharm Int. 23 (10), 3…
Article
Biopharma in 2015: A Year for Approvals and Innovations
Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 2014 and 22% in 2013—which confirms the growing importance of b…
Article
FDA Approves First Biosimilar
Mar 06, 2015
By Randi Hernandez
BioPharm International
FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the firs…
Article
Regulatory Challenges in the QbD Paradigm
Data and trends are collected and analyzed to identify any patterns or trends for specific categories of products or similar products even after drug approval. Metrics are developed to understand the …
Article
mAbs to Watch in 2016
By Randi Hernandez
Of the 45 new molecular entities and new therapeutic biological products approved by FDA in 2015, nine products were monoclonal antibodies (mAbs). And there may be many more o…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
Article
Framing Biopharma Success in 2016
FDA’s expedited pathways for drug approval have proved successful; 60% of the 2015 approvals were designated in one or more of the expedited pathways (fast track, breakthrough, priority review, and ac…
Article
Drug Quality Key to Innovation and Access
As 2016 came to a close, FDA officials reported that new drug approvals for the year would fall far short of the near-record set in 2015, raising concerns about current incentives and regulatory proce…
Article
Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …