Approvals

FDA lifts clinical hold on Cellectis phase 1 trials with UCART123 in AML and BPDCN

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).

FDA advisory committees recommend approval of Indivior’s RBP-6000 to treat opioid use disorder

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 secures FDA approval for mantle cell lymphoma

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.

FDA approves new dosing for Xarelto to reduce risk of VTE

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.

FDA accepts Roche’s sBLA for Avastin to treat women with advanced ovarian cancer

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 gets orphan drug status for SYNB1618 to treat phenylketonuri

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).

Novartis’ cancer combo Tafinlar and Mekinist gets FDA breakthrough status

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 gets two US FDA approvals for Simponi Aria to treat active psoriatic arthritis

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).

FDA approves GSK’s Shingrix to prevent shingles in adults aged 50 and over

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.