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
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 (
Acorda Therapeutics has filed for bankruptcy protection, hoping to keep operating while it tries to arrange the sale of its main assets to a US subsidiary of Germany’s Mer
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.
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)
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