A panel of the European Medicines Agency recommended approving GlaxoSmithKline’s experimental treatment for a common form of blood cancer, days after a similar nod from a U.S. Food and Drug Administration panel.
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending conditional marketing authorization of Novartis’ Adakveo (crizanlizumab) for the prevention of recurrent vaso-occlusive crises, or pain crises, in patients with sickle cell disease aged 16 years and older.
The U.S.Food and Drug Administration approved Jazz Pharmaceuticals’ Xywav as the first new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years.
The U.S. Food and Drug Administration approved MC2 Therapeutics’ Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older.
The U.S. Food and Drug Administration accepted the filing of Aurinia Pharmaceuticals Inc.’s New Drug Application (NDA) for voclosporin as a potential treatment for lupus nephritis, a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus.
The U.S. Food and Drug Administration accepted Acadia Pharmaceuticals Inc.’s application for an antipsychotic drug to treat dementia patients with hallucinations and delusions.
U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
An independent panel to the U.S. Food and Drug Administration voted in favor of approving GlaxoSmithKline’s experimental treatment for a common form of blood cancer, saying the benefits of the treatment outweigh the risks.
The U.S. Food and Drug Administration granted marketing clearance for Janssen Pharmaceutical’s Tremfya as a treatment for active psoriatic arthritis, marking the first time a selective interleukin (IL)-23 inhibitor was approved as a treatment for the chronic progressive disease.
Pfizer Inc. and partner BioNTech SE said two of their experimental coronavirus vaccines received ‘fast track’ designation from the U.S. health agency, speeding up the regulatory review process.
