FDA Issues Guidance on Bioequivalence
Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.
FDA has published Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate. The guidance recommends in-vitro and in-vivo studies to establish bioequivalence (BE) of the test (T) and reference (R) dry powder inhalers containing fluticasone propionate and salmeterol xinafoate.
The guidance recommends single actuation content, aerodynamic particle size distribution in-vitro, and the fasting pharmacokinetic (PK) BE studies for all strengths of the T and R products. Clinical endpoint study is recommended for the lowest strength of the T and R products.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
