FDA – Page 21 – media

FDA approves Renovis Surgical’s 3D-printed posterior lumbar interbody fusion systems

The clearance for 3D-printed Tesera porous titanium interbody fusion systems has been secured from the US Food and Drug Administration (FDA) by Renovis Surgical Technologies.
- Source: orthopedicdevices
- 426
- August 15, 2017
Company Insight FDA interbody lumbar New Approvals
FDA clears AUM’s diagnostic cardiovascular device

The US Food and Drug Administration (FDA) has cleared AUM Cardiovascular’s acoustic and electrocardiogram (ECG) device called CADence to aid detection of physiological and pathological heart murmurs.
- Source: medicaldevice-network
- 453
- August 11, 2017
CADence cardiovascular FDA heart New Approvals
Kite begins EU trial of CAR–T therapy

Kite Pharma has begun treating the first EU patients with its investigational CAR–T candidate, axicabtagene ciloleucel (axi-cel), in the safety expansion cohort of the ZUMA-1 trial.
- Source: pharmatimes
- 834
- August 10, 2017
CAR–T Clinical Trials Company Insight EU FDA
FDA extends review on Dynavax’s Heplisav-B

FDA extends review on Dynavax's hepatitis B vaccine candidate Heplisav-B, but both management and analysts said they remain confident in approval.
- Source: fiercepharm
- 620
- August 7, 2017
Company Insight FDA hepatitis Heplisav-B Market Views vaccine
Emergent secures $23m to develop new auto-injector for US’ DoD

US-based life sciences firm Emergent BioSolutions has secured around $23m for the development of a new multi-drug auto-injector to deliver nerve agent antidote.
- Source: medicaldevice-network.com
- 424
- August 2, 2017
antidote FDA Market Views
FDA clears BD’s immunological IVD system for commercialization

FDA has granted 510(k) clearance to Becton, Dickinson and Company’s (BD) in-vitro diagnostic (IVD) device, FACSLyric flow cytometer system.
- Source: Medicaldevice-network.com
- 525
- July 27, 2017
Clinical FDA immune New Approvals
Teleflex’s arterial catheterisation device obtains FDA clearance

Teleflex has obtained market clearance from the US Food and Drug Administration (FDA) for its Arrow Seldinger arterial catheterisation device.
- Source: Medicaldevice-network-com
- 455
- July 26, 2017
catheter Company Insight diagnostic FDA New Approvals
Aspect Imaging’s neonatal MRI device gains FDA clearance

Aspect Imaging has secured 510(k) clearance for the commercialisation of its neonatal brain and head magnetic resonance imaging (MRI) device from the US Food and Drug Administration (FDA).
- Source: Medicaldevice
- 504
- July 24, 2017
Aspect Imaging Company Insight FDA MRI
FDA approval granted to Emmaus for sickle cell therapy

Emmaus Medical recently received FDA (The U.S. Food and Drug Administration) approval for sickle cell disease therapy Endari (L-gluitamine), ending two decades of drought for treatment of the disease and giving an alternative to the only other drug on the market, hydroxyurea.
- Source: Ddu
- 499
- June 29, 2017
Endari FDA formulation New Approvals
EU regulators reviewing Shire’s bleeding disorder drug

European regulators have validated the marketing authorisation application for Shire’s experimental von Willebrand Disease therapy Veyvondi.
- Source: pharmatimes
- 603
- June 26, 2017
EU FDA genetic therapy

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