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FDA approves Gazyva to treat follicular lymphoma
1 March 2016 | By Victoria White
The FDA has approved Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma...
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Food and Drug Administration (FDA)
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Can surgical robotics become entirely autonomous?
1 March 2016 | By Snehal Chougule, Allied Market Research
The use of robotics in pharmaceutical manufacturing is well established. Here, Snehal Chougule discusses advancements in robotics in medical science that could revolutionise the way patients are treated...
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FDA approves expanded indication for Pfizer’s Ibrance
23 February 2016 | By Victoria White
Ibrance is approved for the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy...
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FDA accepts NDA for Sanofi’s combination of insulin glargine and lixisenatide
23 February 2016 | By Victoria White
This NDA submission is based on data from two Phase 3 studies of insulin glargine and lixisenatide in patients with with type 2 diabetes...
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FDA grants Breakthrough Therapy status to PKC412 (midostaurin)
19 February 2016 | By Victoria White
PKC412 (midostaurin) is an investigational treatment for adults with newly-diagnosed acute myeloid leukaemia who are FLT3 mutation-positive...
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Breakthrough Therapy Designation for ocrelizumab in PPMS
17 February 2016 | By Victoria White
Roche's ocrelizumab is the first investigational medicine to receive Breakthrough Therapy Designation in multiple sclerosis...
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FDA accepts Teflaro sNDA for filing
16 February 2016 | By Victoria White
If approved, this filing will expand the label of Teflaro beyond adults to include the treatment of children two months of age and older...
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Breakthrough Therapy designation for Adaptimmune’s NY-ESO-1-T cell therapy
10 February 2016 | By Victoria White
The Breakthrough Therapy designation was based on the results of a Phase I/II trial in patients with unresectable, metastatic or recurrent synovial sarcoma...
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Orphan Drug Designation for acute spinal cord injury treatment
4 February 2016 | By Victoria White
AST-OPC1 has three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury...
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PDAC supports effectiveness of Brintellix in treating cognitive dysfunction in MDD
4 February 2016 | By Victoria White
The FDA Advisory Committee reviewed data from studies designed to assess the effect of Brintellix on cognitive dysfunction in adult patients with MDD...
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FDA grants Fast Track Designation to TapImmune’s TPIV 200
3 February 2016 | By Victoria White
The FDA has granted the designation for maintenance therapy in subjects with platinum-sensitive advanced ovarian cancer...
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GSK submits sBLA seeking expanded indication for Flulaval Quadrivalent
3 February 2016 | By Victoria White
The submission seeks an expanded indication for Flulaval Quadrivalent in the US for children six months through 35 months of age...
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FDA approves Eisai’s Halaven in liposarcoma
29 January 2016 | By Victoria White
Halaven is the first and only single agent to demonstrate an overall survival benefit in a Phase III trial in patients with leiomyosarcoma or liposarcoma...
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FDA approves Zepatier for treatment of chronic HCV GT1 and GT4
29 January 2016 | By Victoria White
Zepatier is a once-daily, fixed-dose combination tablet containing the NS5A inhibitor elbasvir and the NS3/4A protease inhibitor grazoprevir...
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European Pharmaceutical Review’s top 10 stories from 2015
Mega mergers, 3D printed drugs, a call for action on antimicrobial resistance: 2015 certainly was an interesting year for the pharmaceutical industry. Here we pick a selection of the top stories that hit the headlines.
