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GSK’s RSV vaccine approved by FDA for older adults

Arexvy is the first RSV vaccine for this age group to be approved anywhere in the world

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FDA issues new draft guidance on decentralised clinical trials

The document includes recommendations on trial design and the use of digital health technologies

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Pfizer’s next-generation pneumococcal vaccine granted FDA approval

The vaccine can help protect against 20 serotypes of the streptococcus pneumoniae bacteria

Biogen Idec building

Biogen’s Qalsody granted FDA accelerated approval for rare form of ALS

Mutations in the SOD1 gene are responsible for approximately 2% of all cases

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bluebird bio submits US application for sickle cell gene therapy

The genetic disease affects approximately 100,000 people in the US alone

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FDA approves Gamida’s cell therapy for blood cancer patients

Blood cancers represent about 10% of all annual US cancer cases

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Authorisation for Moderna and Pfizer/BioNTech’s bivalent COVID-19 vaccines simplified by FDA

The vaccines are now authorised for all doses in individuals aged six months and older

The ongoing evolution of Medical Affairs

In the latest episode of Impetus Digital's Fireside Chat series, Natalie Yeadon, Co-Founder and CEO of Impetus Digital talks to Eddie Power, Vice President of North America Medical Affairs, Hospital...

Impetus Digital

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Merck KGaA’s MS drug put on partial clinical hold by FDA

Laboratory results suggested there were two cases of drug-induced liver injury during the phase 3 studies

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FDA proposes improvements for oncology clinical trials supporting accelerated approval

The draft guidance discusses the advantage of randomised clinical trials over single-arm studies

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AbbVie’s Parkinson’s disease therapy application rejected by FDA

The regulator has requested more information on the pump used to administer ABBV-95

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Pfizer and Astellas’ Xtandi shows promise in phase 3 prostate cancer study

The treatment is already approved in the US for three disease states of prostate cancer

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