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Marketing Authorisations

Voxelotor (Oxbryta°) in sickle-cell disease

Tildrakizumab (Ilumetri°) in plaque psoriasis: 200 mg in a pre-filled syringe and 100 mg in a pre-filled pen

Amivantamab (Rybrevant°) in non-small cell lung cancer with an EGFR exon 20 insertion mutation

Osimertinib (Tagrisso°) as adjuvant treatment in certain lung cancers

Trastuzumab deruxtecan (Enhertu°) in HER2-positive gastric cancers after failure of chemotherapy combined with trastuzumab

Intranasal fentanyl (Instanyl° DoseGuard°): finally made safer

Editors' opinion. Don't procrastinate when it comes to safety

Crizanlizumab (Adakveo°): revocation of a marketing authorisation granted too hastily

Vosoritide (Voxzogo°): syringe graduated in international units of insulin!

Adverse Effects

Pregabalin and gabapentin: sometimes fatal overdoses

Inset. Pregabalin: avoid its use for focal seizures and generalised anxiety disorder, just as for neuropathic pain

Crizotinib and sofosbuvir + velpatasvir: increased risk of heart failure and bradycardia

Levonorgestrel-releasing IUDs: increased frequency of ectopic pregnancy

Common stem: -prost-

Outlook

The French National Authority for Health's cost-effectiveness evaluations

Medical devices mimicking medicinal products: the European Court of Justice confirms a strict stance

Mediator°: delays in the reporting of adverse effects

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