• February 21, 2019
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Novo Nordisk has received U.S. FDA approval for Esperoct (turoctocog alfa peg, N8-GP) for the treatment of children and adults with haemophilia A. Today's decision permits physicians to prescribe the drug for...

• February 21, 2019
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Pfizer has won European Commission approval for its Avastin biosimilar Zirabev (bevacizumab). The approval comes on the back of data from the phase III REFLECTIONS B739-03 clinical comparative study which...

• February 19, 2019
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The U.S. FDA have granted priority reviews for Roche's cancer drug polatuzumab vedotin, as well as personalised medication entrectinib. The priority review for polatuzumab veodtin comes on the back of results...

• February 19, 2019
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A report published by market access consultancy MAP BioPharma is pushing for the National Institute for Health and Care Excellence (NICE) to be more 'flexible' with its work with NHS...

• February 18, 2019
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New proposals from the Centers for Medicare and Medicaid Services (CMS) could result in Medicare covering the latest CAR T-cell therapy as a viable treatment for cancer.  Under the terms...

• February 18, 2019
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Roche has bagged NICE backing for Perjeta (pertuxumab) in the prevention of early-stage HER2-positive breast cancer from recurring after surgery, after three attempts. The new draft guidance permits Perjeta to be given...

• February 11, 2019
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The U.S. FDA are set to debate the viability of Johnson & Johnson's esketamine spray for major depression - a medication related to 'party drug' ketamine. Votes from the FDA's advisory committee...

• February 8, 2019
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AstraZeneca’s MEDI8897 has been granted access to both the European Medicines Agency (EMA) PRIME (PRIority MEdicines) scheme, as well as the US Food and Drug Administration’s (FDA) Breakthrough Therapy Designation...

• February 7, 2019
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The U.S. FDA has granted Orphan Drug Designation (ODD) to Fasenra (benralizumab) for the treatment of hypereosinophilic syndrome.  The designation comes on the back of data from a phase II trial conducted...

• February 5, 2019
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Roche is aiming to hasten use of its breast cancer drug Kadcyla with the submission to the FDA under the Real-Time Oncology Review and Assessment Aid programme. Kadcyla (trastuzumab emtansine)...