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.
List view / Grid view
The European Commission has approved Europe's first treatment for adults with indolent systemic mastocytosis, a rare haematological disorder.
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.
Future regulatory authorisation is expected in Europe, following the US Food and Drug Administration (FDA)’s accelerated approval of IXCHIQ®.
The US FDA has approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference blockbuster drug Stelara (ustekinumab).
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.
A new route of administration for a biologic to treat ulcerative colitis (UC) has been approved in the US.
The US FDA approval of Akeega (niraparib and abiraterone acetate) is based on positive results from the Phase III MAGNITUDE study.
Several FDA warning letters distributed to pharmaceutical manufacturers in 2023 have warned of numerous corrective and preventive action (CAPA) compliance concerns.
The European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities in human medicinal products, amending Q&A 10 and adding three appendices.
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.
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).
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.
The first article to broadly assess the US National Institutes of Health (NIH)'s financial contribution to clinical development of new drugs has been published.
The Pharmaceutical Research and Manufacturers of America (PhRMA) has highlighted in a new report five R&D mechanisms that could facilitate full clinical value of oncology treatments after initial approval from the US Food and Drug Administration (FDA).
There continues to be a correlation between low site inspection scores and potential drug recalls, states the US Office of Pharmaceutical Quality (OPQ) 2022 annual report.