Regulatory Filings and Submissions

The agency published recommendations for the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma.

The approval of Nucala (mepolizumab) for treating hypereosinophilic syndrome represents the first drug approved for this group of rare blood disorders in nearly 14 years.

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

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

The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.

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

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

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

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

Regulators strive to review flood of advanced treatments while also vetting COVID-19 vaccines.

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

A new FDA guidance provides answers to such questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.

The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.

The company has launched its biosimilar rituximab, Ritucad, for the Indian market.

The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.

The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).

The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.

The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.

The therapy, indicated for a rare form of B-cell non-Hodgkin’s lymphoma, was developed by Kite, a Gilead company, which will manufacture the therapy at its facility in El Segundo, CA.

Many antibody-drug conjugate therapies are in the pipeline; only a handful have been approved. What are the bottlenecks?

Celltrion Healthcare has announced that the EC has granted marketing authorization for its subcutaneous formulation of Remsima (infliximab, CT-P13).

Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.