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RSS FeedPosted by Michael Wonder on 21 Jan 2021
Impel NeuroPharma announces U.S. FDA acceptance of new drug application for INP104 for the acute treatment of migraine
20 January 2021 - FDA conditionally accepts trade name, Trudhesa, pending approval of the new drug application, and sets PDUFA goal ...
Posted by Michael Wonder on 21 Jan 2021
Doptelet (avatrombopag) approved in the EU for treatment of ITP
20 January 2021 - Sobi today announced that the European Commission has approved an extension of the indication for Doptelet ...
Posted by Michael Wonder on 20 Jan 2021
TGA grants additional provisional determination for a COVID-19 vaccine
20 January 2021 - The TGA, part of the Department of Health, has granted a provisional determination to Biocelect (on ...
Posted by Michael Wonder on 20 Jan 2021
U.S. FDA accepts for priority review application for Opdivo (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastro-oesophageal junction cancer and oesophageal adenocarcinoma
20 January 2021 - U.S. FDA assigned a target action date of 25 May 2021. ...
Posted by Michael Wonder on 20 Jan 2021
U.S. Food and Drug Administration accepts for priority review application for Opdivo (nivolumab) as adjuvant therapy for patients with resected oesophageal or gastro-oesophageal junction cancer
20 January 2021 - Application based on Phase 3 CheckMate-577 trial, in which Opdivo doubled median disease-free survival versus placebo in ...
Posted by Michael Wonder on 20 Jan 2021
AMA call for mass upscaling of home-made drug manufacture
20 January 2021 - The Australian Medical Association has warned of a shortage of essential medications because of supply chain ...
Posted by Michael Wonder on 20 Jan 2021
U.S. FDA approves vericiguat for patients with symptomatic chronic heart failure
20 January 2021 - Vericiguat (Verquvo) is the first soluble guanylate cyclase stimulator to be approved for the treatment of symptomatic ...
Posted by Michael Wonder on 20 Jan 2021
Ontario doctors urge domestic drug manufacturing over fears of pandemic shortage
19 January 2021 - Chronic drug shortages have worsened during pandemic, Ontario Medical Association says. ...
Posted by Michael Wonder on 20 Jan 2021
Is Novavax the dark horse of Australia's COVID-19 vaccines?
19 January 2021 - Experts say early clinical data on Australia's third COVID-19 vaccine, Novavax, is promising enough to suggest ...
Posted by Michael Wonder on 20 Jan 2021
Enhertu approved in the EU for the treatment of HER2 positive metastatic breast cancer
20 January 2021 - Approval based on the DESTINY-Breast01 Phase 2 trial which showed clinically meaningful and durable responses in patients ...
Posted by Michael Wonder on 20 Jan 2021
AstraZeneca COVID-19 vaccine claims ‘not evidence-based’
19 January 2021 - Claims that the AstraZeneca COVID-19 vaccine prevents death “100 per cent of the time” are not ...
Posted by Michael Wonder on 19 Jan 2021
New labelling for antibiotics in Australia
19 January 2021 - The Pharmaceutical Society of Australia is to be applauded for changing the way pharmacists label the antibiotics ...
Posted by Michael Wonder on 19 Jan 2021
Health professionals warn Australia is struggling to deal with post-COVID-19 medication shortage
20 January 2021 - Australians with chronic health conditions are having to take drastic stop-gap measures because of a continuing ...
Posted by Michael Wonder on 19 Jan 2021
Taysha Gene Therapies receives rare paediatric disease and orphan drug designations for TSHA-105 for the treatment of epilepsy caused by SLC13A5 deficiency
19 January 2021 - Designations reinforce unmet need for treatment options for patients with rare form of genetic epilepsy. ...
Posted by Michael Wonder on 19 Jan 2021
Biologics license application for narsoplimab in HSCT-TMA accepted for priority review by U.S. FDA
19 January 2021 - FDA sets PDUFA date of 17 July 2021. ...