Regulatory Authority Actions

May 23, 2018
Right-to-Try bill sent to White House for President’s signature after passage by Congress.
May 21, 2018
By BioPharm International Editors
The agency approved Amgen and Novartis’ Aimovig (erenumab-aooe), the first FDA-approved preventive treatment for migraine in adults.
May 17, 2018
By BioPharm International Editors
The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.
May 16, 2018
By BioPharm International Editors
The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).
May 14, 2018
By BioPharm International Editors
FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
May 14, 2018
President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.
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.
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