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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

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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The draft guidance discusses the advantage of randomised clinical trials over single-arm studies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 pays Royalty Pharma $475m following US approval of migraine nasal spray

Royalty Pharma signed a deal for the programme in 2020 with Biohaven, which Pfizer has since acquired

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Roche’s Polivy backed by FDA Advisory Committee for lymphoma therapy

Around 160,000 people worldwide are estimated to be diagnosed with DLBCL each year

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Eli Lilly/Boehringer’s Jardiance for children with type 2 diabetes accepted by FDA

The incidence of type 2 diabetes in children has nearly doubled over the past two decades

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Eli Lilly’s Verzenio label expanded by FDA for early breast cancer patients

The decision removes the previous 20% Ki-67 score requirement for patient selection

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