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In final draft guidance, the National Institute for Health and Care Excellence (NICE) has recommended dapagliflozin (Forxiga) for patients with heart failure regardless of ejection fraction.
The European Medicines Agency (EMA) has made recommendations for industry on how to prevent medicine shortages and reduce their impact.
Gilead Science’s antiviral medication for chronic hepatitis D has been recommended by the National Institute for Health and Care Excellence (NICE).
The European Commission (EC) has given approval to the first PEGylated enzyme replacement therapy to treat Fabry disease.
Public consultation seeks the best methods for balancing transparency with confidentiality in the EU Clinical Trials Information System, says the European Medicines Agency.
The US Food and Drug Administration (FDA) has approved the first-ever vaccine for respiratory syncytial virus (RSV) in adults over 60 years old.
CD19-directed CAR T-cell therapy Breyanzi has been approved by the European Commission (EC) based on significant results from a lymphoma Phase III trial.
Recommendations on the conduct of remote clinical trial visits are included in new US Food and Drug Administration (FDA) draft guidance.
Industry bodies EPFIA and the Alliance for Regenerative Medicine and law firm Pinsent Masons have responded to the recent proposed revision of the EU pharmaceutical legislation.
Solving the sector-specific challenges of life sciences while enabling innovation requires data integrity, with data collected and analysed at the source in real time, explains Greg Hookings, Industry Director, Stratus Technologies.
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…
