07/07/24 | ARQT | Roflumilast Cream 0.15%(sNDA) | FDA decision on Roflumilast Cream 0.15% for the treatment of atopic dermatitis in adults and children down to age 6 |
06/30/24 | RCKT | RP-L201 (BLA) | FDA decision on KRESLADI (RP-L201) for severe Leukocyte Adhesion Deficiency-I |
06/28/24 | GMAB | Epcoritamab-bysp (sBLA) | FDA decision on Epcoritamab-bysp for expanded use in treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy |
06/28/24 | ABBV | Epcoritamab-bysp (sBLA) | FDA decision on Epcoritamab-bysp for expanded use in treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy |
06/27/24 | SNYNF, SNY | Dupixent(sBLA) | FDA decision on Dupixent for treatment of chronic obstructive pulmonary disease (COPD) with type 2 inflammation |