Alofisel® (formerly Cx601 / darvadstrocel) is the first allogeneic stem cell therapy to...
- Changing trends in real-world evidence
- AAAAI/WAO 2018: Stallergenes Greer presents US paediatric safety data for Oralair
- Aimmune’s AR101 shows outstanding efficacy in Phase III Trial—now it’s time to improve safety
- Verastem’s duvelisib seeks FDA approval for relapsed or refractory CLL
- Continued growth for GLP-1 receptor agonists and SGLT-2 inhibitors in 2017
Alofisel (darvadstrocel) for the Treatment of Complex Perianal Fistulas in Crohn’s Disease
Alofisel® (formerly Cx601 / darvadstrocel) is the first allogeneic stem cell therapy to be approved for the treatment of complex perianal fistulas in adult patients with Crohn’s disease.
TAVALISSE (fostamatinib disodium hexahydrate) for the Treatment of Chronic Immune Thrombocytopenia
TAVALISSE™ is a twice-daily regimen indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who have had an insufficient response to a previous treatment.
FDA approves Opdivo/Yervoy combo treatment for kidney cancer
The US Drug and Food Administration (FDA) has approved a combination therapy using Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for advanced renal cell carcinoma (RCC). Both drugs are produced by Bristol-Myers Squibb (BMS).
FDA grants fast track designation to Proteostasis CF therapy
The US Food and Drug Administration (FDA) has given fast track designation to a triple combination programme in cystic fibrosis (CF) patients developed by biopharma Proteostasis Therapeutics.
Sanofi seeks EMA approval for asthma drug Dupixent
The European Medicines Agency (EMA) has accepted Sanofi’s application to review its drug Dupixent (dupilumab) as an add-on maintenance treatment in patients aged 12 years and older with inadequately controlled moderate-to-severe asthma.
Cynata’s GvHD treatment receives Orphan Drug Designation
Regenerative medicine company Cynata Therapeutics has announced that the US Food and Drug Administration (FDA) has given Orphan Drug Designation to CYP-001, its treatment for acute graft versus host disease (GvHD).
Is IL-23 the new hot target for Psoriasis?
On March 21, the FDA approved Sun Pharma’s Ilumya (tildrakizumab) for the treatment of adults with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Ilumya marks the second interleukin-23 (IL-23) inhibitor to gain FDA approval within the past year, following the approval of J&J’s Tremfya (guselkumab) in July 2017.
Siklos (hydroxyurea) for the Treatment of Children with Sickle Cell Anaemia
Siklos® is an orally administered tablet form of hydroxyurea that is indicated for the treatment of sickle-cell anaemia in paediatric patients aged two years and older.
Zinbryta (daclizumab) for the Treatment of Multiple Sclerosis
Zinbryta (daclizumab) is an injectable formulation jointly developed by Biogen and Abbive for the treatment of relapsing forms of multiple sclerosis (MS) in adults.
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