Search Results for “FDA” – Page 62 – media

Janssen Closes in on Seeking FDA Approval for Ketamine-Based Depression Treatment

Janssen Pharmaceuticals is eying a potential breakthrough in treating refractory major depressive disorder. The company plans to seek regulatory approval for its ketamine-based esketamine nasal spray this year and if given the green light it will be the first new approach for the indication in nearly 50 years.
- Source: biospace
- 573
- May 11, 2018
depressive disorder Janssen
FDA Approves CAR T Therapy for Large B-Cell Lymphoma Developed at University of Pennsylvania

Nation’s first approved personalized cellular therapy now available for second indication
- Source: pennmedicine.org
- 526
- May 8, 2018
B-cell lymphoma FDA Kymriah
FDA approve iSchemaView’s 3D CTA

iSchemaView has received FDA approval for its latest product, RAPID CTA, a 3D imaging platform for computed tomography angiography (CTA).
- Source: drugdu
- 3,537
- May 4, 2018
digital health FDA imaging New Approvals
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
- 3,679
- 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
- 629
- 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
- 611
- April 28, 2018
digital health FDA Policies
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
- 627
- 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
- 609
- 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
- 659
- April 26, 2018
blindness diabetic retinopathy FDA IDx-DR New Approvals
FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis

Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis (RA) for adult patients who have had an inadequate response or intolerance to methotrexate. While the Advisory Committee unanimously supported the efficacy of the 4-mg dose of baricitinib, it did not recommend approval of the 4-mg dose of baricitinib for the proposed indication based on the adequacy of the safety and benefit-risk profiles.
- Source: prnewswire
- 678
- April 25, 2018
baricitinib Eli Lilly New Approvals RA

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