Bird Rock Bio has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a phase 2 clinical study of nimacimab, also known as RYI-018, in patients with one of the following renal diseases: diabetic kidney disease, focal segmental glomerulosclerosis (FSGS), or immunoglobulin A (IgA) nephropathy.
29 May 2020
28 May 2020
GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) has granted a priority review for the company’s application seeking approval of Nucala (mepolizumab) in the treatment of patients with Hypereosinophilic Syndrome (HES) in the US.
26 May 2020
Novaremed is seeking the approval of the US Food and Drug Administration (FDA) to begin a phase 2 trial for evaluating its new drug candidate NRD135S.E1 for the treatment of painful diabetic peripheral neuropathy (PDPN).
20 May 2020
Tolero Pharmaceuticals submits investigational new drug application for experimental PKM2 activator TP-1454
Tolero Pharmaceuticals, a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its investigational small-molecule pyruvate kinase M2 isoform (PKM2) activator, TP-1454.
18 May 2020
Can-Fite announces pre-IND submission to US FDA for Piclidenoson in treatment of Covid-19 infected patients with moderate-to-severe symptoms
Can-Fite BioPharma, a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it has filed a pre-Investigational New Drug (IND) meeting request with the U.S. Food and Drug Administration (FDA) for its drug candidate Piclidenoson in the treatment of COVID-19 patients with moderate-to-severe symptoms.
15 May 2020
08 May 2020
Daiichi Sankyo submits sNDA for trastuzumab deruxtecan in Japan for HER2 positive metastatic gastric cancer
Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for trastuzumab deruxtecan (DS-8201), a HER2 directed antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic gastric cancer.
05 May 2020
Acceleron Pharma said that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH).
04 May 2020
FDA accepts for priority review Bristol Myers Squibb’s application for CC-486 for maintenance treatment of adults in remission with AML
Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for CC-486 for the maintenance treatment of adults in remission with acute myeloid leukemia (AML)
27 Apr 2020
Janssen announces submission of two applications to US FDA seeking approval of SIMPONI ARIA to treat polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA® (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients two years of age and older in combination with methotrexate