New Approvals – Page 23 – media

NICE flip-flops to back Bristol’s Opdivo in head and neck cancer despite data ‘uncertainties’

Back in April, England’s cost watchdogs said they wouldn’t cover Bristol-Myers Squibb’s Opdivo in head and neck cancer due to “uncertain” clinical evidence. Now, though, they’re singing a different tune.
- Source: Fiercepharm
- 550
- October 16, 2017
New Approvals NHS Opdivo
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
- 521
- 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
- 545
- 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
- 820
- 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
- 754
- 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
- 678
- October 11, 2017
FDA New Approvals plasma Zika
AstraZeneca’s Tagrisso Gets Breakthrough Therapy Designation

AstraZeneca announced that the FDA has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
- Source: finance.yahoo
- 579
- October 10, 2017
Company Insight EGFR FDA New Approvals NSCLC
Alcon gets CE-Mark for new preloaded IOL delivery system

Novartis’ division Alcon has obtained CE-Mark for its AutonoMe preloaded intraocular lens (IOL) delivery system to accurately deliver the IOL into the capsular bag during cataract surgery. The AutonoMe system is preloaded with a new biomaterial called Clareon IOL that features an advanced design for sharp vision, low edge glare and enhanced optic clarity. With an automated CO2-powered delivery mechanism, the preloaded system is intended to enable accurate single-handed control of IOL placement. Alcon CEO Mike Ball said: “With the introduction of Clareon AutonoMe, we are proud to unveil our latest innovations to benefit doctors and their patients undergoing cataract surgery. “Clareon AutonoMe builds upon the comprehensive legacy of AcrySof by offering cataract surgeons easy, intuitive control of IOL delivery with the newest optic material.” “The intuitive and easy-to-use device is expected to simplify the procedure and minimise surgical time.” The intuitive and easy-to-use device is expected to simplify the procedure ...
- Source: medicaldevice-network
- 536
- October 10, 2017
cataract Company Insight IOL New Approvals
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
- 836
- 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
- 877
- September 30, 2017
breast cancer FDA New Approvals therapy

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