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Accelerated approval

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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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Pfizer to acquire Seagen for $43bn in biggest pharma transaction since 2019

The deal includes four approved medicines and Seagen’s antibody-drug conjugate technology

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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

Medscape Oncology: Delivering Impact at ASH

You can read more information on Medscape Oncology at ASH here, or please reach out to Chris Carey or Steve Dunn who can tell you more about how Medscape can help to...

Medscape Education Global

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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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FDA authorises first at-home COVID-19 and flu test for emergency use

The single-use test uses nasal swab samples and provides results in about 30 minutes

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Sanofi and Sobi’s once-weekly haemophilia A treatment approved by FDA

Current factor VIII therapies usually require patients to receive treatment every two days

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