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EMA starts review of Rocket’s Fanconi anaemia gene therapy

Patients in the EU with Fanconi anaemia (FA) could soon have the first gene therapy option for the disorder, as the EMA starts a review of Rocket Pharma’s RP-L102 candidat

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AZ, Daiichi Sankyo file Dato-DXd for second indication

AstraZeneca and Daiichi Sankyo have moved swiftly to file for FDA approval of a second indication for their TROP2-directed antibody-drug conjugate datopotamab deruxtecan (

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FDA clears first DTx for depression from Otsuka, Click

Otsuka and Click Therapeutics’ Rejoyn has become the first prescription digital therapeutic (DTx) to be approved by the FDA for people with major depressive disorder.

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FDA clears AZ’s new PNH therapy Voydeya

AstraZeneca’s Voydeya has become the first oral Factor D inhibitor to be approved by the FDA as a treatment for the rare disease paroxysmal nocturnal haemoglobinuria (PNH)

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Leqembi maintenance dose filed in US, but SC form delayed

Eisai has filed to extend the label for its Alzheimer’s disease therapy Leqembi to include a maintenance dosing regimen that would reduce the number of intravenous infusio

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Report claims WuXi shared US client IP with China

US intelligence services advised the authors of the BIOSECURE Act that that WuXi AppTec shared confidential data on US customers with the Chinese government, according to

EMA starts review of Rocket’s Fanconi anaemia gene therapy

AZ, Daiichi Sankyo file Dato-DXd for second indication

FDA clears first DTx for depression from Otsuka, Click

FDA clears AZ’s new PNH therapy Voydeya

Leqembi maintenance dose filed in US, but SC form delayed

Report claims WuXi shared US client IP with China

BridgeBio gains on phase 3 dwarfism data

How to meet your physicians where they are online

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