Regulatory Authority Actions

Nov 16, 2018
By BioPharm International Editors
The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.
Nov 15, 2018
By BioPharm International Editors
The new good pharmacovigilance practice chapter IV on specific considerations for the pediatric population offers a holistic view of pediatric pharmacovigilance and provides guidance on how to address the specific needs and challenges of safety monitoring of medicines used in children.
Nov 15, 2018
By BioPharm International Editors
The agency provided an update on its relocation plans and assured that core activities are continuing uninterrupted.
Nov 14, 2018
By BioPharm International Editors
The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.
Nov 12, 2018
By BioPharm International Editors
The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.
Nov 08, 2018
By BioPharm International Editors
The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.
Nov 08, 2018
By BioPharm International Editors
Leaders of the two parties are open to challenging the status quo on drug costs and spending.
Nov 02, 2018
By BioPharm International Editors
The company received FDA approval for Hyrimoz (adalimumab-adaz), its biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).
Oct 30, 2018
By BioPharm International Editors
The companies announced the European launch of Imraldi (adalimumab), a biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).
Oct 30, 2018
By BioPharm International Editors
Mylan announced the launch of its biosimilar to AbbVie’s Humira across major European markets.
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