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Australia’s TGA granted approval for AbbVie’s Skyrizi® (risankizumab) in a higher, 150mg/mL  concentration formulation. Skyrizi® is indicated for plaque psoriasis in adults.

Novartis announced that China’s NMPA has expanded its approval of Cosentyx® (secukinumab) to include the treatment of plaque psoriasis in paediatric patients.

Novartis announced the results of its Ph III trials of Beovu® (brolucizumab) versus aflibercept in patients with diabetic macular edema, reporting that Beovu® demonstrated superiority versus aflibercept in key endpoints.

The FDA announced the Biosimilar User Fee Act rates for the 2022 fiscal year. The new rates will apply from 01 October 2021.

Roche notified Australia’s TGA of shortages of multiple presentations of Actemra® (tocilizumab). Tocilizumab has been used off-label for COVID-19, driving global demand. The TGA made a number of recommendations for patients currently treated with Actemra®, including switchi...

Progenity released its Q2 2021 financial results. Progenity disclosed that it has recently produced a GMP drug substance batch for its adalimumab oral biotherapeutics delivery system (PGN-0B1).

Brazil’s ANVISA granted emergency use authorisation (EUA) for Celltrion’s COVID‑19 treatment regdanvimab.