FDA – Page 6 – media

Tisagenlecleucel Granted FDA Approval for Large B-Cell Lymphoma

Based on data from the phase II JULIET study, tisagenlecleucel (Kymriah) has received FDA approval for the treatment of adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.
- Source: targetedonc
- 3,683
- May 3, 2018
FDA New Approvals tisagenlecleucel
FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) for Treatment of Advanced Cervical Cancer

First Filing Acceptance for an Anti-PD-1 Therapy in Cervical Cancer
- Source: investors.merck
- 633
- May 2, 2018
cervical cancer FDA keytruda Merck
FDA plans to launch ‘Pre Cert 1.0’ by the end of 2018, issues working model for digital health regulation

The Food and Drug Administration plans to launch a full-scale version of its digital health precertification program by the end of the year.
- Source: FiercePharma
- 614
- April 28, 2018
digital health FDA Policies
Foundation Medicine’s New Liquid Biopsy Assay Granted Breakthrough Device Designation by U.S. Food and Drug Administration

Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation (formerly Expedited Access Pathway program) for its new liquid biopsy assay, which is an expanded version of its FoundationACT® assay. The new assay will include more than 70 genes and genomic biomarkers for microsatellite instability (MSI) and blood tumor mutational burden (bTMB). If approved, this test could be the first FDA-approved liquid biopsy assay to incorporate multiple companion diagnostics (CDx) and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies.
- Source: nvestors.foundationmedicine
- 585
- April 27, 2018
FDA liquid biopsy assay microsatellite instability
Once-daily Trelegy Ellipta gains expanded indication in the US for the treatment of patients with COPD

GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the US Food and Drug Administration (FDA) has approved an expanded indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), which means this medicine can now be used by US physicians to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms.
- Source: us.gsk
- 642
- April 27, 2018
Company Insights COPD FDA GSK
AbbVie Submits Biologics License Application to U.S. FDA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis

In clinical studies, more than half of patients receiving risankizumab achieved complete skin clearance (PASI 100) at one year (52 weeks) (1) The Biologics License Application is supported by four Phase 3 studies of more than 2,000 patients with moderate to severe plaque psoriasis (1-3) Risankizumab is an investigational compound designed to selectively inhibit IL-23 by binding to its p19 subunit and is being evaluated for the potential to deliver long-term skin clearance for psoriasis patients with 12-week dosing (4)
- Source: prnewswire
- 644
- April 27, 2018
AbbVie FDA New Approvals plaque psoriasis
As FDA’s Pre-Cert plan takes shape, worries emerge about overreach

Yesterday morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD). Though still preliminary (the agency is asking for comments by the end of May), the publication comes with some long-awaited details about how the program might work.
- Source: MobiHealthNews
- 615
- April 27, 2018
FDA medical device products Policies
FDA to expedite review of IDx-DR, a breakthrough AI diagnostic system

IDx, a privately held AI diagnostics company, announced today that it has filed its De Novo submission to the FDA for IDx-DR, an AI-based system for the autonomous detection of diabetic retinopathy — a leading cause of blindness. The FDA has granted IDx-DR with a “Breakthrough Device” designation, which means the submission will receive expedited review.
- Source: prweb
- 666
- April 26, 2018
blindness diabetic retinopathy FDA IDx-DR New Approvals
Steth IO launches digital stethoscope housed within smartphone case

On Tuesday, Bothell, Washington-based Steth IO announced the launch of its smartphone-based digital stethoscope.
- Source: MobiHealthNews
- 842
- April 26, 2018
FDA medtech mHealth New Approvals
Urotronic gets OK for advanced trial to treat narrowed urethras

Plymouth-based medical device maker Urotronic is ramping up clinical research on its Optilume drug-coated balloon to treat men with narrowed urethras, accelerating the data-gathering process for its novel device.
- Source: StarTribune
- 1,916
- April 26, 2018
FDA medical device medtech Researches

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