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Sarepta Therapeutics

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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The draft guidance discusses the advantage of randomised clinical trials over single-arm studies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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FDA approves intramuscular administration of Merck’s MMRV vaccines

Until now, the vaccines have only been administered via subcutaneous injection

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FDA grants priority review for traditional approval of Biogen and Eisai’s Alzheimer’s drug

Leqembi was granted accelerated approval in the US earlier this year

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Pfizer’s RSV vaccine candidate for older adults backed by FDA Advisory Committee

RSV infections in older adults account for 60,000 to 160,000 hospitalisations each year in the US

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