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RSS FeedPosted by Michael Wonder on 04 Jan 2021
Provention Bio announces U.S. FDA filing of a biologics license application and priority review for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk Individuals
4 January 2020 - FDA sets PDUFA goal date of 2 July 2021. ...
Posted by Michael Wonder on 04 Jan 2021
US FDA accepts regulatory submission from Pfizer and OPKO for review of somatrogon to treat pediatric patients with growth hormone deficiency
4 January 2020 - If approved, somatrogon will serve as a once-weekly treatment option. ...
Posted by Michael Wonder on 04 Jan 2021
TGA still waiting for 'further data' on AstraZeneca vaccine
4 January 2020 - Concerns over new coronavirus cases in Sydney and Melbourne look unlikely to prompt an accelerated approval ...
Posted by Michael Wonder on 01 Jan 2021
CytRx issues statement regarding U.S. regulatory review of arimoclomol for Niemann-Pick disease type C
31 December 2020 - CytRx today provided an update on the U.S. FDA review of Orphazyme new drug application for arimoclomol ...
Posted by Michael Wonder on 31 Dec 2020
Tetra Bio-Pharma files new drug submission for Reduvo in Canada
30 December 2020 - The addressable market is estimated to be $80 million CDN by 2022. ...
Posted by Michael Wonder on 30 Dec 2020
Update on rolling review of AstraZeneca’s COVID-19 vaccine
30 December 2020 - EMA’s assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University has been progressing ...
Posted by Michael Wonder on 30 Dec 2020
Bristol Myers Squibb statement on Opdivo (nivolumab) small cell lung cancer U.S. indication
29 December 2020 - In 2018, Opdivo (nivolumab) was granted accelerated approval by the U.S. FDA for the treatment of patients ...
Posted by Michael Wonder on 30 Dec 2020
Osmotica Pharmaceuticals receives complete response letter from U.S. Food and Drug Administration for arbaclofen extended release tablets
29 December 2020 - Osmotica Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter regarding the Company's ...
Posted by Michael Wonder on 30 Dec 2020
Novo Nordisk files for EU regulatory approval of once weekly semaglutide 2 mg for the treatment of type 2 diabetes mellitus
29 December 2020 - Novo Nordisk today announced the submission of a label extension application to the EMA for the existing ...
Posted by Michael Wonder on 30 Dec 2020
Eyenovia submits new drug application to FDA for pharmacologic mydriasis with MydCombi targeting 80 million patient encounters in the U.S. annually
29 December 2020 - Eyenovia today announced that it has submitted a new drug application to the U. S. FDA ...
Posted by Michael Wonder on 29 Dec 2020
FDA accepts Alkermes' resubmission of new drug application for ALKS 3831
29 December 2020 - FDA sets PDUFA target action date of 1 June 2021. ...
Posted by Michael Wonder on 29 Dec 2020
Vertex announces new drug submission for investigational triple combination medicine for the treatment of cystic fibrosis has been accepted for priority review by Health Canada
28 December 2020 - Vertex Pharmaceuticals Incorporated today announced its New Drug Submission for Trikafta, Vertex’s investigational triple combination medicine, ...
Posted by Michael Wonder on 29 Dec 2020
Y-mAbs announces sale of priority review voucher
28 December 2020 - Y-mAbs Therapeutics today announced that it has entered into a definitive agreement to sell its priority ...
Posted by Michael Wonder on 29 Dec 2020
European Medicines Agency validates Bristol Myers Squibb’s application for Zeposia (ozanimod) for the treatment of ulcerative colitis
28 December 2020 - Marketing authorisation application is supported by positive results from the pivotal Phase 3 True North trial evaluating ...
Posted by Michael Wonder on 29 Dec 2020
Janssen submits European marketing authorisation application for amivantamab for the treatment of patients with metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
28 December 2020 - If approved, amivantamab will be the first-ever treatment specifically targeting EGFR exon 20 insertion mutations in the ...