11 April 2023 - Approval supported by pivotal Phase 3 study that demonstrated reliable infection protection in children 2-16 years pld. ...
3 April 2023 - First and only therapy approved to treat this rare and debilitating genetic condition. ...
31 March 2023 - The positive opinion is based on final data from the 52 week Phase 3 PANORAMA-HF trial, the ...
22 March 2023 - Approval extends Evkeeza to children aged 5 to 11 with homozygous familial hypercholesterolaemia, an inherited condition characterised ...
21 March 2023 - Milestone marks third Dupixent European Commission approval in the past four months. ...
16 March 2023 - Today, the FDA approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for paediatric patients 1 year ...
14 March 2023 - Today, the US FDA amended the emergency use authorisation of the Pfizer-BioNTech COVID-19 vaccine, bivalent to provide ...
8 March 2023 - The application is based on phase III results from the DINAMO trial showing Jardiance (empagliflozin) tablets significantly ...
7 March 2023 - If approved, remestemcel-L will be the first allogeneic “off the shelf” cellular medicine in the US and ...
7 March 2023 - FDA set PDUFA target action date of 21 October 2023. ...
1 March 2023 - Pfizer and BioNTech today submitted an application to the US FDA for emergency use authorisation of ...
23 February 2023 - The authorisation is an important step to meet ViiV Healthcare’s commitment to bring paediatric formulations to children ...
17 February 2023 - The recommendation is based on clinical data for Moderna's bivalent Omicron targeting COVID-19 vaccine, mRNA.1273.214. ...
13 February 2023 - FDA assigns second quarter 2023 target action date. ...
8 February 2023 - Adtralza is the first treatment for adolescents with moderate to severe atopic dermatitis specifically targeting the ...