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RSS FeedPosted by Michael Wonder on 12 Jan 2021
U.S. FDA accepts for priority review the biologics license application for V114, Merck’s investigational 15 valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older
12 January 2021 - Merck today announced the U.S. FDA accepted for priority review a biologics license application for V114, Merck’s ...
Posted by Michael Wonder on 12 Jan 2021
U.S. FDA grants priority review to new drug application for finerenone to treat patients with chronic kidney disease and type 2 diabetes mellitus
12 January 2021 - Bayer announced today that the U.S. FDA has accepted its new drug application and granted priority review ...
Posted by Michael Wonder on 12 Jan 2021
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
12 January 2020 - EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca ...
Posted by Michael Wonder on 12 Jan 2021
Health Canada approves Bavencio for the maintenance treatment of patients with advanced bladder cancer
11 January 2021 - Bavencio is the first and only maintenance therapy for unresectable locally advanced or metastatic urothelial carcinoma ...
Posted by Michael Wonder on 12 Jan 2021
Acrux receives FDA approval for its generic testosterone topical solution
12 January 2021 - Acrux is pleased to announce that the US FDA has approved its generic product based on ...
Posted by Michael Wonder on 12 Jan 2021
ObsEva provides update on Yselty (linzagolix) clinical development program
11 January 2021 - European Medicines Agency validates Yselty marketing authorisation application for uterine fibroids; US NDA Planned for 1H 2021. ...
Posted by Michael Wonder on 12 Jan 2021
Aerie Pharmaceuticals receives European Commission approval for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%
11 January 2021 - Aerie Pharmaceuticals today announced the European Commission has granted a marketing authorisation for Roclanda (netarsudil and latanoprost ...
Posted by Michael Wonder on 11 Jan 2021
Exicure granted two fast track designations for cavrotolimod (AST-008) from the U.S. Food and Drug Administration
11 January 2021 - Exicure today announced that the U.S. FDA has granted fast track designations for its clinical product ...
Posted by Michael Wonder on 11 Jan 2021
Organogenesis ReNu receives FDA regenerative medicine advanced therapy designation for osteoarthritis of the knee
11 January 2021 - FDA determines ReNu preliminary clinical evidence indicates potential to address unmet medical needs for the management of ...
Posted by Michael Wonder on 11 Jan 2021
US FDA accepts supplemental new drug application for Jardiance (empagliflozin) for adults with heart failure with reduced ejection fraction
11 January 2021 - The U.S. FDA has accepted a supplemental new drug application for Jardiance (empagliflozin) which is being ...
Posted by Michael Wonder on 11 Jan 2021
Roche’s Xofluza approved by the European Commission for the treatment of influenza, the first new influenza antiviral for patients in almost 20 years
11 January 2021 - The European Commission has approved single-dose, oral Xofluza for the treatment of uncomplicated influenza in patients aged ...
Posted by Michael Wonder on 11 Jan 2021
FDA takes steps to provide clarity on developing new drug products in the age of individualised medicine
4 January 2021 - Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug ...
Posted by Michael Wonder on 10 Jan 2021
U.S. FDA approves addition of overall survival and other secondary outcome data to Nubeqa (darolutamide) Prescribing Information
8 January 2021 - Phase 3 data showed treatment with Nubeqa resulted in a 31% reduction in risk of death, with ...
Posted by Michael Wonder on 10 Jan 2021
2020: a strong year for new drug therapy approvals – despite many COVID-19 challenges
8 January 2021 - Throughout 2020, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research was challenged ...
Posted by Michael Wonder on 08 Jan 2021
Praxis Precision Medicines receives rare paediatric disease and orphan drug designations for severe paediatric epilepsy programs
7 January 2021 - FDA grants RPD and ODD for PRAX-222 for treatment of SCN2A-DEE. ...