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First-in-class therapy approved for chronic skin disease
The biologic treatment targets a key driver of prurigo nodularis, with trial data demonstrating improved itch as well as skin nodules for patients with the condition.
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The US Food and Drug Administration (FDA)
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Regulating therapies for rare diseases – recent approvals
This article summarises some of the recent notable drug approvals in the EU and US, including a gene therapy and an enzyme replacement therapy.
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FDA approves innovative engineered cell therapy
The accelerated approval by the US Food and Drug Administration (FDA) authorises the first engineered cell therapy for a solid tumour in the US.
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EC approves treatment for rare haematological disorder
The European Commission has approved Europe's first treatment for adults with indolent systemic mastocytosis, a rare haematological disorder.
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FDA approves first cell-based gene therapies for sickle cell disease
The US FDA has approved Vertex’s Casgevy and bluebird bio’s Lyfgenia, for one-time treatment of sickle cell disease in patients 12 years and older.
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First chikungunya vaccine approved
Future regulatory authorisation is expected in Europe, following the US Food and Drug Administration (FDA)’s accelerated approval of IXCHIQ®.
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FDA approves first Stelara biosimilar, Wezlana
The US FDA has approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference blockbuster drug Stelara (ustekinumab).
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Guidance on machine learning-enabled medical devices published
The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have issued guidelines to reduce the regulatory burden for machine learning-enabled medical devices.
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Takeda ulcerative colitis biologic receives FDA approval
A new route of administration for a biologic to treat ulcerative colitis (UC) has been approved in the US.
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FDA approval for Janssen’s prostate cancer treatment
The US FDA approval of Akeega (niraparib and abiraterone acetate) is based on positive results from the Phase III MAGNITUDE study.
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FDA warning letters highlight CAPA concerns
Several FDA warning letters distributed to pharmaceutical manufacturers in 2023 have warned of numerous corrective and preventive action (CAPA) compliance concerns.
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EMA revises guidance on nitrosamine impurities
The European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities in human medicinal products, amending Q&A 10 and adding three appendices.
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Strengthening and transforming the pharmaceutical supply chain
In this exclusive interview, Naser Al Yammahi, Deputy CEO of Hayat Biotech explores challenges facing the pharmaceutical supply chain, medicine shortages and looks at how technology advances will drive supply chain transformation.
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Beyfortus approved for US infants against RSV disease
The only monoclonal antibody approved for passive immunisation to protect infants in their first RSV season has been approved by the US Food and Drug Administration (FDA).
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First continuous mRNA manufacturing platform to be developed
Design of the world’s first continuous mRNA manufacturing platform, an $82 million, three-year, FDA-funded project aims to help accelerate development of mRNA technologies.
