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21 December 2015 | By Victoria White
The FDA has authorised Celyad’s IND application to proceed, thus allowing for the clinical testing of C-Cure cardiopioetic cells delivered via C-Cathez in a Phase III heart failure trial...
17 December 2015 | By Victoria White
The FDA has approved Basaglar for the treatment of adult and paediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus...
14 December 2015 | By Victoria White
Vistogard is the first and only antidote for 5-FU and capecitabine overdose and for earlyonset, severe, life-threatening toxicities approved by the FDA...
14 December 2015 | By Victoria White
Alecensa (alectinib) is approved for patients whose disease has worsened after, or who could not tolerate treatment with Xalkori (crizotinib)...
9 December 2015 | By Victoria White
Vonvendi [von Willebrand factor (Recombinant)] is the first and only recombinant treatment for adults living with von Willebrand Disease (VWD)...
9 December 2015 | By Victoria White
Kanuma (sebelipase alfa) has been approved for the treatment of patients with a diagnosis of lysosomal acid lipase deficiency (LAL-D)...
3 December 2015 | By ChemAcademy
The FDA and EU published a lot of guidlines regarding process validation which makes it hard to keep up with all the changes...
1 December 2015 | By Victoria White
Empliciti (elotuzumab) has been approved as combination therapy with Revlimid (lenalidomide) and dexamethasone (ERd) in patients who have received one to three prior therapies.
26 November 2015 | By Victoria White
ABP 501 is a biosimilar candidate to AbbVie’s Humira (adalimumab), an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of various inflammatory diseases...
25 November 2015 | By Victoria White
The approval is based on the Phase III study where the Portrazza regimen demonstrated a significant improvement in overall survival...
24 November 2015 | By Victoria White
BioThrax is the first vaccine to receive approval based on the Animal Rule. The Animal Rule allows animal efficacy data to be used as a basis for approval when human efficacy studies are not ethical or feasible...
24 November 2015 | By Victoria White
The announcement marks the approval of the first and only PD-1 inhibitor to deliver significant overall survival in patients with advanced renal cell carcinoma...
23 November 2015 | By Victoria White
Ninlaro (ixazomib) is the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma...
19 November 2015 | By Victoria White
Until this approval, naloxone was only approved in injectable forms, most commonly delivered by syringe or auto-injector...
18 November 2015 | By Victoria White
Avelumab (MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody...
