FDA Grants Breakthrough Designation to Johnson & Johnson’s Novel Treatment for HR-NMIBC
December 5th 2023TAR-200 has a novel targeted releasing system for the treatment of patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer who are ineligible for bladder removal surgery.
FDA Grants Priority Review to Bristol Myers Squibb's Opdivo Combination for Urothelial Carcinoma
December 5th 2023The FDA assigned a PDUFA date of April 5, 2024 for Opdivo (nivolumab) plus cisplatin-based chemotherapy for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.
Roche Bolsters Obesity, Diabetes R&D Portfolio With Acquisition of Carmot Therapeutics
December 4th 2023Roche announces definitive merger agreement to acquire Carmot Therapeutics, Inc., which has an R&D portfolio that includes clinical stage subcutaneous and oral incretins for the treatment of patients with obesity, both with and without diabetes.
FDA Approves Lilly's Jaypirca for Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
December 4th 2023Jaypirca (pirtobrutinib) granted accelerated approval by the FDA for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously administered least two prior lines of therapy that included a BTK inhibitor and a BCL2 inhibitor.
FDA Grants Priority Review to Keytruda Plus Padcev for Urothelial Carcinoma
December 1st 2023The FDA previously granted accelerated approval to the Keytruda plus Padcev combination for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.
FDA Fast Tracks eFFECTOR Therapeutics' Zotatifin Combo for ER+/HER2– Breast Cancer
December 1st 2023FDA to expedite review of zotatifin plus Faslodex (fulvestrant) and Verzenio (abemaciclib) as a second- or third-line treatment for patients with estrogen receptor–positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer whose disease progressed after treatment with endocrine therapy and a CDK4/6 inhibitor.
FDA Accepts Arcutis Biotherapeutics' sNDA for Roflumilast Cream for Atopic Dermatitis
November 30th 2023Supplemental new drug application for roflumilast cream 0.15% to treat atopic dermatitis in patients 6 years of age and older was assigned a Prescription Drug User Fee Act target action date of July 07, 2024.
FDA Investigating Risk of Secondary Cancers in Patients Administered CAR T-Cell Therapy
November 29th 2023The FDA will investigate all currently approved CAR T-cell treatments, as well as BCMA-directed and CD19-directed genetically modified autologous CAR T-cell therapies, for the risk of secondary T-cell malignancies.