Search Results for “FDA” – Page 75 – media

FDA Okays Another CAR T-Cell Therapy

The FDA has approved a second chimeric antigen receptor (CAR) T-cell therapy for cancer: Kite Pharma's axicabtagene ciloleucel (Yescarta) for the treatment of certain types of refractory large B-cell lymphoma, the agency announced.
- Source: medpagetoday
- 739
- October 19, 2017
cancer CAR–T FDA New Approvals
FDA panel votes in favor of Spark’s blindness gene therapy

Spark Therapeutics Inc's experimental gene therapy for a rare form of blindness improves vision and should be approved, advisers to the Food and Drug Administration concluded on Thursday, paving the way for the first U.S. gene therapy for an inherited disease.
- Source: cnbc
- 1,012
- October 17, 2017
Company Insight gene inherited therapy
Respicardia gets FDA approval for remede system to treat sleep apnea

The US Food and Drug Administration (FDA) has approved Respicardia’s transvenous implantable neurostimulation system, remede, for moderate to severe central sleep apnea (CSA) in adults.
- Source: medicaldevice-network
- 517
- October 13, 2017
CSA FDA neurostimulation New Approvals
FDA Grants Priority Review To Gilotrif For Uncommon EGFR Mutations In Advanced NSCLC

Boehringer Ingelheim announced that the supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 21 (L861Q), G719X or S768I substitution mutations as detected by an FDA-approved test.
- Source: careers.biospace
- 541
- October 13, 2017
EGFR New Approvals NSCLC sNDA
FDA approves LivaNova’s VNS therapy system for epilepsy

UK-based firm LivaNova has obtained approval from the US Food and Drug Administration (FDA) for its new Vagus Nerve Stimulation (VNS) Therapy System designed to treat drug-resistant epilepsy.
- Source: medicaldevice-network
- 815
- October 12, 2017
Company Insight epilepsy New Approvals VNS
FDA grants orphan drug status to UniQure’s Huntington’s Disease treatment

Dutch biotech UniQure has won orphan drug designation (ODD) for its investigational treatment for Huntington’s Disease, a rare, inherited neurodegenerative disorder that leads to loss of muscle coordination, behavioural abnormalities and cognitive decline.
- Source: 4-traders
- 752
- October 12, 2017
Huntington’s Disease neurodegenerative New Approvals ODD
Roche secures FDA approval for Zika virus screening test

Roche has secured approval from the US Food and Drug Administration (FDA) for its cobas Zika test to detect RNA of the Zika virus in human plasma samples.
- Source: medicaldevice-network
- 673
- October 11, 2017
FDA New Approvals plasma Zika
FDA awards 15 grants for clinical trials to stimulate product development for rare diseases

The U.S. Food and Drug Administration(FDA) announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country.
- Source: fda.gov
- 612
- October 9, 2017
Clinical FDA rare diseases Researches
FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration

The U.S. Food and Drug Administration(FDA) approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”).
- Source: fda.gov
- 830
- September 30, 2017
FDA Glucose Monitoring System New Approvals
FDA approves new treatment for certain advanced or metastatic breast cancers

The U.S. Food and Drug Administration(FDA) approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy).
- Source: fda.gov
- 861
- September 30, 2017
breast cancer FDA New Approvals therapy

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.