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The UK’s MHRA has stated that manufacturers must instead issue a Declaration of Conformity to Directive 93/42/EEC and register their Class I medical device with an EU Competent Authority.
The all-in-one, Control-IQ system controlled the blood glucose levels of children aged six and over more successfully than standard technologies in a clinical trials.
The trial will assess the safety, tolerability and immunogenicity of the five-in-one MenABCWY vaccine in participants aged 10 to 25.
The European Commission and European Medicines Agency have approved the triple combination Kaftrio for use in certain cystic fibrosis patients, triggering the drug to be accessible on the UK’s National Health Service.
The Phase I trial will assess the safety and pharmacokinetics of the AZD7442 monoclonal antibody combination in 48 healthy participants.
According to Medicure, AGGRASTAT (tirofiban hydrochloride) has shown promise for preventing and treating thrombotic complications due to COVID-19.
The emergency use authorisation (EUA) allows the distribution and administration of COVID-19 convalescent plasma to hospitalised patients in the US.
Therapyx and Intravacc will jointly develop NGoXIM, a microsphere vaccine which is designed to stimulate adaptive immunity against gonorrhoea.
The Phase II clinical trial to study NVX-CoV2373, the Novavax COVID-19 vaccine candidate, has enrolled its first patient.
Stempeucel®, a cell therapy for the treatment of Critical Limb Ischemia (CLI), has been approved for commercial use in India by the Drug Controller General.
Kesimpta was approved based on trial results showing the monthly injection significantly reduced the relapse rate and disability progression of MS patients compared to a currently approved treatment.
Researchers reveal that for early breast cancer a single dose of targeted intraoperative radiotherapy (TARGIT-IORT) is as effective at preventing breast cancer recurrence as the standard of care.
The FDA has released guidance on its compliance policy on reserve samples used in bioavailability and bioequivalence studies.
Sanofi is set to acquire Principia Biopharma Inc. for a total aggregate equity value of $3.68 billion, at $100 per share.
A preliminary analysis of data from the first COVID-19 pneumonia patients enrolled in the ODYSSEY trial revealed that tradipitant may expedite clinical improvement.
