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RSS FeedPosted by Michael Wonder on 14 Jan 2021
Innovation Pharmaceuticals’ brilacidin for the treatment of COVID-19 receives FDA fast track designation
14 January 2021 - Innovation Pharmaceuticals is pleased to announce that the U.S. FDA has designated as a fast track development ...
Posted by Michael Wonder on 14 Jan 2021
FDA veteran Woodcock being considered to lead agency under Biden
14 January 2021 - Joshua Sharfstein, former Obama FDA official, also in running. ...
Posted by Michael Wonder on 14 Jan 2021
Novartis ligelizumab (QGE031) receives FDA breakthrough therapy designation for patients with chronic spontaneous urticaria
14 January 2021 - Ligelizumab is the first treatment to receive FDA Breakthrough Therapy designation in chronic spontaneous urticaria in patients ...
Posted by Michael Wonder on 14 Jan 2021
FDA releases artificial intelligence/machine learning action plan
12 January 2021 - Today, the U.S. FDA released the agency’s first artificial intelligence/machine learning-based software as a Medical Device Action ...
Posted by Michael Wonder on 14 Jan 2021
Workshop on evaluating RWE from observational studies in regulatory decision-making
12 January 2021 - The FDA and the Duke-Margolis Center for Health Policy will hold a virtual workshop focused on ...
Posted by Michael Wonder on 14 Jan 2021
Amneal launches generic abiraterone acetate 500 mg tablets following ANDA approval by FDA
8 January 2021 - Amneal Pharmaceuticals announced that it has received approval of an additional strength of 500 mg to its ...
Posted by Michael Wonder on 13 Jan 2021
Cognito Therapeutics receives FDA breakthrough device designation for next-generation digital therapeutic in Alzheimer’s disease
12 January 2021 - Breakthrough designation is based on positive outcomes from clinical studies, and will advance the industry’s first next-generation ...
Posted 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 ...