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FDA grants Priority Review to ixazomib for multiple myeloma
10 September 2015 | By Victoria White
Ixazomib is the first investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma...
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Food and Drug Administration (FDA)
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FDA grants breakthrough therapy designation to Roche’s ACE910
4 September 2015 | By Victoria White
Breakthrough therapy designation has been granted to ACE910 for the prophylactic treatment of people with haemophilia A with factor VIII inhibitors...
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FDA grants Fast Track designation to iclaprim
3 September 2015 | By Victoria White
The FDA has granted Fast Track designation to iclaprim to treat acute bacterial skin and skin structure infections and hospital acquired bacterial pneumonia...
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FDA approves label update for Teflaro
2 September 2015 | By Victoria White
Teflaro is now approved for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia...
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FDA accepts supplemental Biological License Application for Opdivo
2 September 2015 | By Victoria White
The FDA has accepted for filing and review the supplemental Biological licence Application for Opdivo for the treatment of patients with non-squamous NSCLC...
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FDA grants priority review for Empliciti Biologics License Application
2 September 2015 | By Victoria White
The FDA has accepted for priority review the BLA for Empliciti (elotuzumab) for the treatment of multiple myeloma as combination therapy...
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FDA approves LDL cholesterol drug Repatha
28 August 2015 | By Victoria White
Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, has been approved by the FDA for some patients who are unable to get their LDL cholesterol under control with current treatment options...
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FDA approves Praluent for the treatment of high LDL cholesterol
26 August 2015 | By Victoria White
The US Food and Drug Administration (FDA) has approved Praluent (alirocumab) Injection - the first and only PCSK9 inhibitor approved in the US...
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FDA approves label expansion for Promacta
25 August 2015 | By Victoria White
The FDA has approved a label expansion for Promacta to treat low blood platelet count in paediatric patients with chronic immune thrombocytopenic purpura...
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FDA approves female libido drug Addyi
19 August 2015 | By
The US FDA has approved Sprout’s Addyi (flibanserin) to treat acquired, generalised hypoactive sexual desire disorder (HSDD) in premenopausal women...
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FDA approves first ever 3D printed drug product: Spritam
4 August 2015 | By Victoria White
The FDA has approved 3D printed drug Spritam for the treatment of of partial onset seizures, myoclonic seizures and generalised tonic-clonic seizures...
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FDA accepts Mundipharma EDO’s IND for EDO-S101
3 August 2015 | By Victoria White
The FDA has accepted Mundipharma EDO’s IND for EDO-S101, a fusion molecule to treat relapsed/refractory haematologic malignancies and solid tumours...
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Roche submits filing to FDA for Cobas EGFR Mutation Test v2
31 July 2015 | By Victoria White
Roche submitted the cobas EGFR Mutation Test v2 for Premarket Approval (PMA) to the FDA, as a companion diagnostic test for AZD9291...
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Eisai’s Lenvima receives Breakthrough Therapy designation for renal cell carcinoma
29 July 2015 | By Victoria White
Eisai has received a Breakthrough Therapy designation for Lenvima for the potential indication of advanced and/or metastatic renal cell carcinoma...
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FDA approves Technivie for GT4 chronic HCV
27 July 2015 | By Victoria White
The US FDA has approved AbbVie’s Technivie in combination with ribavirin for the treatment of adults with genotype 4 chronic hepatitis C virus infection...
