Tags : Us FDA

Regulatory

AbbVie Submits Regulatory Applications to the US FDA and EMA

Shots: The submission is based on two P-III studies KEEPsAKE-1 & -2 studies involves assessing Skyrizi (150mg) vs PBO in adult patients with active PsA who had an inadequate response or intolerant to biologic therapy and/or non-biologic DMARDs respectively The 1EP and 2EP of both studies showed ACR20 response @24wks., improvements in disease activity, skin […]Read More

Clinical Trials

Ocular Therapeutix Reports sNDA Submission of Dextenza (dexamethasone ophthalmic insert)

Shots: The sNDA submission is based on P-II/P-III Clinical trial assessing Dextenza(dexamethasone ophthalmic insert, 0.4mg) vs PBO for the treatment of Ocular Itching associated with allergic conjunctivitis Result: At 1EPs for the pooled analysis of P-III clinical trial at Day 8; ocular itching favored DEXTENZA treated participants compared with PBO at all 3-time points: 3 […]Read More

Regulatory

Janssen Initiates Rolling Submission of BLA to US FDA of

Shots: Janssen Initiates Rolling Submission of BLA to US FDA is based on P-lb/ll CARTITUDE-1 Study involve evaluating the safety and efficacy of Autoleucel (cilta-cel) in adults for the treatment of relapsed and refractory Multiple Myeloma The FDA granted BTD for cilta-cel and agreed to BLA’s rolling review includes completed portions of the application to […]Read More