Regulatory

May 10, 2018
By BioPharm International Editors
The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.
May 08, 2018
By BioPharm International Editors
The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.
May 07, 2018
By BioPharm International Editors
The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.
May 07, 2018
Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
Apr 24, 2018
By BioPharm International Editors
EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.
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.
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