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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Testing various tablet-splitting devices showed how well they performed.
Data integrity violations have led to a need for better and more consistent validation management practices.
The bio/pharma industry is accelerating efforts to manage its data and documents more effectively.
May 26, 2022
Dupixent (dupilumab), developed by Regeneron Pharmaceuticals in partnership with Sanofi, has received FDA approval for a new indication—treating eosinophilic esophagitis, a chronic inflammatory disease.
May 24, 2022
A new initiative aims to speed the approval of and access to new drugs for young patients around the world, while limiting the number of children needed for testing in clinical trials.
AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.
EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.
May 23, 2022
PTC Therapeutics has received a positive opinion from EMA for Upstaza for the treatment of AADC deficiency.
The final guidance addresses safety aspects of container and carton labeling design.
May 20, 2022
The agency is asking drug manufacturers to ensure a strong supply chain by developing risk management plans.
FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.
May 18, 2022
Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.
The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.