FDA grants priority review to Merck’s new drug application for vericiguat

16 July 2020 - Application based on first contemporary outcomes study focused exclusively on chronic heart failure patient population following a ...

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Knopp Biosciences receives rare paediatric disease designation for Kv7 activator KB-3061 for treatment of KCNQ2 epileptic encephalopathy

15 July 2020 - Knopp Biosciences announced today that it has received rare paediatric disease designation from the U.S. FDA ...

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Improving clinical trial enrollment — In the COVID-19 era and beyond

15 July 2020 - More than 3 million people in the United States are known to have been infected with SARS-CoV-2.  ...

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The COVID-19 vaccine development multiverse

14 July 2020 - Leaving in its wake more than 12 million infections, over 550,000 deaths, and an economic toll in ...

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FDA grants breakthrough therapy designation for Roche's CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma

14 July 2020 - Tenth breakthrough therapy designation awarded for Roche's haematology medicines. ...

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Tremfya (guselkumab) approved by U.S. Food and Drug Administration as the first selective interleukin-23 inhibitor for active psoriatic arthritis

14 July 2020 - In two Phase 3 clinical trials, Tremfya significantly improved signs and symptoms in joints, skin and soft ...

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Verrica Pharmaceuticals receives complete response letter from the FDA for its new drug application for VP-102 for the treatment of molluscum contagiosum

14 July 2020 - Complete response letter requests additional chemistry, manufacturing, and controls and human factors information. ...

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Teva announces availability of ProAir Digihaler (salbutamol sulphate 117 mcg) inhalation powder for patients with asthma and COPD

13 July 2020 - First and only digital rescue inhaler with built-in sensors now available by prescription to patients in the ...

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FDA advises CytoDyn its application is incomplete

13 July 2020 - CytoDyn announced today it has received a refusal to file letter from the U.S. FDA regarding ...

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Pfizer and BioNTech granted FDA fast track designation for two investigational mRNA-based vaccine candidates against SARS-CoV-2

13 July 2020 - Anticipated large, global Phase 2b/3 safety and efficacy study may begin as early as July 2020. ...

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Ipsen announces updated indication for Dysport (abobotulinumtoxinA) for the treatment of spasticity in children

10 July 2020 - Dysport is now FDA approved to treat both upper and lower limb spasticity in paediatric patients two ...

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COVID-19 is forcing us to rethink clinical trials for cancer treatments

9 July 2020 - Participation rates were already low, but the pandemic threatens to drive them even lower. ...

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Remdesivir: US purchase of world stocks sparks new “hunger games,” warn observers

 3 July 2020 - The US has bought up almost all the world’s supply of the antiviral drug remdesivir in ...

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FDA approves expanded Botox (onabotulinumtoxinA) label for the treatment of paediatric patients with spasticity

9 July 2020 - Updated label now includes paediatric patients with lower limb spasticity caused by cerebral palsy. ...

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Leo Pharma announces U.S. FDA acceptance of biologics license application for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis

9 July 2020 - Submission includes data from pivotal ECZTRA 1, 2 and ECZTRA 3 Phase 3 studies evaluating safety and ...

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