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RSS FeedPosted by Michael Wonder on 13 Jan 2021
Leading BioSciences announces FDA fast track designation granted to LB1148 for the treatment of post-operative gastro-intestinal dysfunction associated with paediatric cardiovascular surgery
13 January 2021 - LBS expects to initiate a pivotal trial in 2021. ...
Posted by Michael Wonder on 12 Jan 2021
STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies
12 January 2021 - In alignment with the International Council of Harmonization’s strategic goals, a public private consortium has developed a ...
Posted 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
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 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
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. ...
Posted by Michael Wonder on 08 Jan 2021
FDA statement on following the authorised dosing schedules for COVID-19 vaccines
4 January 2021 - Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease ...
Posted by Michael Wonder on 08 Jan 2021
Inversago Pharma receives rare paediatric disease designation from the FDA for INV-101 for the treatment of Prader-Willi syndrome
7 January 2021 - Inversago Pharma today announced the U.S. FDA granted a rare paediatric disease designation to the Company’s lead ...
Posted by Michael Wonder on 07 Jan 2021
Gemini Therapeutics announces FDA fast track designation granted for GEM103 for the treatment of dry age-related macular degeneration in patients with complement factor H loss of function gene variants
7 January 2020 - Gemini Therapeutics today announced that GEM103, the Company’s investigational treatment for dry age-related macular degeneration, has been ...