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18 November 2015 | By Victoria White
VK2809 is a novel, orally available small molecule thyroid receptor agonist that possesses selectivity for liver tissue as well as the beta receptor subtype...
17 November 2015 | By Victoria White
Darzalex (daratumumab) is the first human anti-CD38 monoclonal antibody (mAb) approved anywhere in the world...
16 November 2015 | By Victoria White
Adynovate has been shown to reduce the number of bleeding episodes during routine care...
13 November 2015 | By Victoria White
Tagrisso (AZD9291) is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer...
13 November 2015 | By Victoria White
AbbVie has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for labelling considerations based on safety and efficacy results from the Phase III HELIOS trial investigating the use of Imbruvica (ibrutinib) plus bendamustine and rituximab (BR) versus placebo plus BR in relapsed or…
13 November 2015 | By Victoria White
The FDA has approved Harvoni for expanded use in patients with genotype 4, 5 and 6 chronic HCV infection and in patients co-infected with HIV...
11 November 2015 | By Victoria White
The approval is for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma...
3 November 2015 | By Victoria White
This is the third Breakthrough Therapy Designation granted for Keytruda. The drug was previously granted breakthrough status for advanced melanoma and advanced non-small cell lung cancer (NSCLC)...
3 November 2015 | By Victoria White
The Breakthrough Therapy Designation was granted based on results from an extension cohort of a Phase 1 study that assessed the safety and efficacy of pexidartinib...
29 October 2015 | By Victoria White
This approval is based on clinical data from a pivotal Phase 3 trial which demonstrated Yervoy significantly improved recurrence-free survival vs. placebo in this setting...
28 October 2015 | By Victoria White
Imylgic is a genetically modified herpes simplex virus type 1 designed to replicate within tumours and produce an immunostimulatory protein called GM-CSF...
26 October 2015 | By Victoria White
The approval was based on recently published clinical efficacy and safety data from a Phase 3 study which evaluated Yondelis versus the chemotherapy agent dacarbazine...
23 October 2015 | By HORIBA Scientific
HORIBA Scientific, global leader in Raman spectroscopy systems for over 50 years, announces the release of their new ProtectionPlus module for the acclaimed LabSpec 6 Spectroscopy Suite...
21 October 2015 | By Victoria White
Until this orphan drug approval, no specific coagulation factor replacement therapy was available in the US for patients with hereditary Factor X deficiency...
19 October 2015 | By Victoria White
Pfizer’s investigational antibody-drug conjugate inotuzumab ozogamicin has received Breakthrough Therapy designation for acute lymphoblastic leukaemia...
