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RSS FeedPosted by Michael Wonder on 14 Jan 2021
Health Canada approves Imbruvica (ibrutinib) plus rituximab for the treatment of patients with chronic lymphocytic leukaemia
13 January 2021 - Patients aged 70 or younger with previously untreated CLL lived longer without disease progression compared to patients ...
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
Push for Australia to develop a world-leading coronavirus vaccine
13 January 2021 - Australia could take the lead in a worldwide quest to find a long-term solution to COVID-19, ...
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 13 Jan 2021
Swissmedic authorises COVID-19 Vaccine Moderna for use in Switzerland
12 January 2021 - Swiss Federal Government has secured 7.5 million doses and first deliveries expected to begin in January. ...
Posted by Michael Wonder on 13 Jan 2021
Health Canada approves Onureg (azacitidine tablets), first maintenance therapy for patients in remission from acute myeloid leukaemia
12 January 2021 - Onureg has shown clinically meaningful increase in overall survival for patients. ...
Posted by Michael Wonder on 13 Jan 2021
MorphoSys and Incyte announce acceptance by Health Canada of the new drug submission for tafasitamab
12 January 2021 - MorphoSys and Incyte today announced that Health Canada has accepted the new drug submission for tafasitamab, an ...
Posted by Michael Wonder on 13 Jan 2021
Health Canada approves Lundbeck's Vyepti (eptinezumab)--the first and only intravenous preventive treatment for migraine
12 January 2021 - Lundbeck is pleased to announce that Vyepti (eptinezumab) has been approved by Health Canada for the preventive ...
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
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 ...