The US Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on Phase 1 trials of Cellectis’ UCART123 product candidate in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Indivior has announced that the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration (FDA) voted 18 to 1 to recommend approval of RBP-6000 for the treatment of opioid use disorder (OUD).
AstraZeneca’s Calquence (acalabrutinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
Janssen Pharmaceuticals reported that 10mg once-daily dose of Xarelto (rivaroxaban) has been approved by the US Food and Drug Administration (FDA) for reducing the continued risk for recurrent venous thromboembolism (VTE) after at least six months of initial anticoagulation therapy.
Roche has announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental biologics license application (sBLA) for Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of women with advanced ovarian cancer.
Synlogic has secured orphan drug status from the US Food and Drug Administration (FDA) for o SYNB1618 preclinical-stage drug candidate for the treatment of phenylketonuria (PKU).
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation after complete resection.
Janssen Biotech announced that the US Food and Drug Administration (FDA) has approved Simponi Aria (golimumab), the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS).
GlaxoSmithKline’s (GSK) Shingrix (Zoster Vaccine Recombinant, Adjuvanted) vaccine has been approved by the US Food and Drug Administration (FDA) for the prevention of herpes zoster (shingles) in adults aged 50 years and over.
Kite Pharma’s chimeric antigen receptor T cell (CAR T) therapy Yescarta (axicabtagene ciloleucel) has been approved by the US Food and Drug Administration for the treatment of relapsed or refractory large B-cell lymphoma in adult patients who had at least two lines of systemic therapy.
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