November 4th 2024
Results from the VENTURE Phase II trial and a Phase I oral formulation study found that VK2735, a novel a dual GLP-1 and GIP receptor agonist, demonstrated promise in treating obesity.
Merck Halts Phase III Trial of Keytruda Combination for Non-Small Cell Lung Cancer
December 7th 2023Trial of Keytruda (pembrolizumab) plus chemotherapy and maintenance Lynparza (olaparib; AstraZeneca, MSD) for the treatment of metastatic squamous non-small cell lung cancer stopped after data did not show a survival benefit.
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.
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.
Follicular Lymphoma Drug Co-Developed by AbbVie and Genmab Gets FDA Breakthrough Designation
November 27th 2023AbbVie and Genmab will share commercial responsibilities in the United States and Japan for epcoritamab-bysp (Epkinly), whereas AbbVie will be responsible for further global commercialization.
FDA Approves Keytruda Plus Chemotherapy for Gastric, Gastroesophageal Junction Adenocarcinoma
November 17th 2023Merck's pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy approved for the first-line treatment of patients with locally advanced unresectable or metastatic, HER2-negative gastric/GEJ adenocarcinoma.
FDA Approves Truqap Plus Faslodex for Advanced HR-Positive Breast Cancer
November 17th 2023Capivasertib (Truqap) plus fulvestrant (Faslodex) is a first-of-its-kind combination for HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1 or PTEN biomarker alterations.
FDA Approves CorMedix Inc’s Treatment for Bloodstream Infections in Patients Receiving Dialysis
November 15th 2023Defencath is indicated for the prevention and treatment of catheter-related bloodstream infections in adults with kidney failure administered chronic hemodialysis via a central venous catheter.