Regulatory Authority Actions

Sep 17, 2018
By BioPharm International Editors
FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.
Sep 14, 2018
By BioPharm International Editors
The agency approved AstraZeneca’s Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia.
Sep 14, 2018
By BioPharm International Editors
FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.
Sep 12, 2018
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
Sep 10, 2018
FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.
Sep 04, 2018
By BioPharm International Editors
As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.
Sep 01, 2018
BioPharm International
More consistent and reliable production processes are critical for advancing innovative treatments.
Aug 30, 2018
By BioPharm International Editors
The European Commission (EC) has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.
Aug 28, 2018
By BioPharm International Editors
The European Commission (EC) has approved Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Aug 27, 2018
The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.
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