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June 29, 2017
The agency announced a plan to eliminate its existing orphan designation request backlog.
June 27, 2017
The agency announced it is taking steps to increase competition within the prescription drug market.
June 23, 2017
The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.
June 02, 2017
Approval of breakthrough therapies requires expedited quality assessment.
May 16, 2017
The agency released several new and revised guidance documents regarding product-specific generic drug development.
May 05, 2017
CPhI expert, Girish Malhotra believes drug costs could be lower if approval timeframes can be cut from 10 to three months.
April 21, 2017
The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.
April 17, 2017
FDA denies the NDA for the RA drug developed by Eli Lilly and Incyte, citing the need for more data.
April 13, 2017
Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.
April 07, 2017
A drop in US drug approvals was noted but this trend was not yet seen in Europe.