Regulatory

Jan 11, 2018
By BioPharm International Editors
The European Commission has approved AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.
Jan 11, 2018
By BioPharm International Editors
The agency is requiring safety label changes to limit the use of prescription opioid cough and cold medicines in children younger than 18 years old.
Jan 05, 2018
By BioPharm International Editors
FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.
Jan 05, 2018
By BioPharm International Editors
FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.
Jan 01, 2018
BioPharm International
Gene therapies highlight FDA new drug approvals in 2017.
Jan 01, 2018
BioPharm International
Scientific advances and renewed investment may infuse biopharma for growth.
Dec 28, 2017
By BioPharm International Editors
The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.
Dec 20, 2017
By BioPharm International Editors
FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.
Dec 19, 2017
By BioPharm International Editors
Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, have filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.
Dec 14, 2017
By BioPharm International Editors
The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.
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