Regulatory

Apr 19, 2018
By BioPharm International Editors
The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.
Apr 16, 2018
By BioPharm International Editors
A new report gives an overview of the work of the International API Inspection Program.
Apr 09, 2018
By BioPharm International Editors
Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.
Apr 03, 2018
By BioPharm International Editors
The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.
Mar 29, 2018
By BioPharm International Editors
Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.
Mar 29, 2018
By BioPharm International Editors
EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).
Mar 19, 2018
By BioPharm International Editors
The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.
Mar 13, 2018
By BioPharm International Editors
Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
Mar 09, 2018
By BioPharm International Editors
The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).
Mar 07, 2018
By BioPharm International Editors
The agency has approved a new HIV treatment for patients with "limited treatment options".
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