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The first and only fully human biologic that directly inhibits interleukin-17A has been granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP).
University of Oxford-developed R21/Matrix-M malaria vaccine has secured approval in two African countries.
Shown to increase myeloma remission times by more than two years, a combination treatment that uses a monoclonal antibody has been approved by NICE.
25 April 2023 | By Merck KGaA
Watch this webinar where Aurélie Chambon will discuss best practices for inventory control and documentation as well as strategies for managing inventory in a compliant manner.
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
Janssen states Imbruvica® plus venetoclax will provide "a much-needed new treatment option" for chronic lymphocytic leukaemia.
Regulatory changes along a drug’s lifecycle should ensure that the health benefits of pharmaceuticals, which have a large ecological footprint, do not cost the environment. Dorothea Baltruks, Research Associate at the Centre for Planetary Health Policy, outlines how forthcoming EU pharmaceutical legislation could pave the way to solutions.
A first-line B-cell lymphoma treatment shown to reduce the risk of disease progression or relapse by 27 percent has been approved by the FDA.
The first allogeneic stem cell transplant therapy to be approved based on Phase III study results has been granted by the US Food and Drug Administration (FDA).
Carissa Kendall-Windless and Sian Banks of law firm Pinsent Masons discuss the development of psychedelic medicines and the legal and regulatory challenges that must be overcome for psychedelics to become safe and effective treatment options in Europe.
With no new first-line treatment for de-differentiated liposarcoma in over forty years, Dr Christoph Zehendner, Medical Director of Boehringer Ingelheim UK and Ireland discusses the company’s ILAP designation of its investigational, innovative treatment.
Samsung Bioepis’ first haematology biosimilar, which references Soliris (eculizumab), has been recommended for approval by the CHMP.
In the European Medicines Agency's March human medicines committee meeting, nine new medicines were recommended, including one for multiple sclerosis.
Sublicence agreements signed by the Medicines Patent Pool (MPP) and three generic manufacturers could enable millions to access a long-acting HIV medicine.
Final draft guidance published by the National Institute for Health and Care Excellence (NICE) has recommended immunotherapy pembrolizumab drug for advanced cervical cancer.
