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RSS FeedPosted by Michael Wonder on 03 Nov 2020
FDA approves updated label for Endari
3 November 2020 - Emmaus Life Sciences announced today revised prescribing information for Endari to better inform healthcare professionals and sickle ...
Posted by Michael Wonder on 03 Nov 2020
Is it time for the FDA to be independent?
3 November 2020 - Public health experts and lay observers alike have expressed concerns that, under political pressure, the FDA ...
Posted by Michael Wonder on 03 Nov 2020
The FDA's cutoff for COVID-19 vaccine effectiveness is 50 percent. What does that mean?
3 November 2020 - Over the summer, the FDA announced that in order for an experimental COVID-19 vaccine to get ...
Posted by Michael Wonder on 03 Nov 2020
Food and Drug Administration accepts BioMarin's new drug application for vosoritide to treat children with achondroplasia
2 November 2020 - If approved, first therapy in U.S. for the treatment of achondroplasia. ...
Posted by Michael Wonder on 03 Nov 2020
Gilead faces pressure to relinquish valuable FDA voucher awarded with remdesivir approval
2 November 2020 - A prominent advocacy group is asking Gilead Sciences to relinquish a valuable voucher that came with ...
Posted by Michael Wonder on 03 Nov 2020
European Medicines Agency validates marketing application for filgotinib for the treatment of ulcerative colitis
2 November 2020 - Application based on results from pivotal Phase 2b/3 SELECTION trial. ...
Posted by Michael Wonder on 03 Nov 2020
Provention Bio completes rolling submission of the biologics license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk individuals
2 November 2020 - Submission of chemistry, manufacturing and controls and administrative information modules represent completion of the Company's submission for ...
Posted by Michael Wonder on 02 Nov 2020
European Commission approves Zejula (niraparib) as first-line monotherapy maintenance treatment in advanced ovarian cancer
29 October 2020 - Zejula is the first PARP inhibitor approved as monotherapy in the European Union for patients with platinum-responsive ...
Posted by Michael Wonder on 02 Nov 2020
GSK Nucala (mepolizumab) filings accepted by European Medicines Agency for three additional eosinophil-driven diseases
29 October 2020 - Submissions based on positive data from pivotal studies in hypereosinophilic syndrome, chronic rhinosinusitis with nasal polyps and ...
Posted by Michael Wonder on 02 Nov 2020
Novartis' MONALEESA-7 Kisqali (ribociclib succinate) study demonstrated statistically significant improvement in overall survival in pre- and peri-menopausal women with HR+/HER2- advanced breast cancer
2 November 2020 - Novartis Pharmaceuticals Canada is pleased to announce that statistically significant overall survival results for Kisqali (ribociclib succinate) ...
Posted by Michael Wonder on 02 Nov 2020
European Commission approves Roche’s Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
2 November 2020 - Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved in Europe for ...
Posted by Michael Wonder on 02 Nov 2020
Janssen submits paliperidone palmitate 6 month supplemental new drug application to U.S. FDA for treatment of schizophrenia in adults
2 November 2020 - If approved, paliperidone palmitate 6 month will be the first and only long-acting injectable schizophrenia treatment with a ...
Posted by Michael Wonder on 02 Nov 2020
Takeda price hikes for a GI drug may give some patients another kind of stomachache
2 November 2020 - Two weeks ago, Takeda Pharmaceuticals raised the list price of its Entyvio treatment for ulcerative colitis ...
Posted by Michael Wonder on 02 Nov 2020
DBV Technologies announces filing and validation of marketing authorisation application for Viaskin Peanut by European Medicines Agency
2 November 2020 - DBV Technologies today announced that its marketing authorisation application for its investigational product Viaskin Peanut (DBV712) has ...
Posted by Michael Wonder on 01 Nov 2020
FDA approves Bronchitol for US market
2 November 2020 - Pharmaxis to manufacture product and export to USA. ...