Quality Systems

Articles

FDA and EMA have accepted the biologics license application and marketing authorization application, respectively, for bimekizumab.

EMA and FDA Accept UCB’s Marketing Applications for Bimekizumab

The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.

Korean MFDS Approves Celltrion’s IND for Phase II/III Trial of COVID-19 Treatment

The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.

EMA Endorses Dexamethasone for Use in COVID-19 Patients on Oxygen Therapy

The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.

EMA Recommends Seven Medicines for Approval

GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.

GenSight Biologics Submits Application to Market Lumevoq in the EU

Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.

AstraZeneca Gains EU Approval for Imfinzi to Treat ES-SCLC

As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.

Vaccine Developers Pledge to Stand with Science

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19. 

FDA’s “Gold Standard” Critical for Biopharma R&D

The agency is reviewing an application for Dexamethasone Taw for treating adult patients with COVID-19.

EMA Evaluating COVID-19 Treatment

BioMarin received the complete response letter for valoctocogene roxaparvovec, its gene therapy intended for treating severe hemophilia A.

Regulatory Filings and Submissions