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RSS FeedPosted by Michael Wonder on 28 Apr 2021
FDA begins review of GC Pharma’s blood product for marketing authorisation
27 April 2021 - The U.S. FDA has entered a full review of GC Pharma’s intravenous immunoglobulin therapy GC5107 for ...
Posted by Michael Wonder on 28 Apr 2021
Takeda announces U.S. FDA grants priority review for new drug application for mobocertinib (TAK-788) as a treatment for EGFR exon 20 insertion positive metastatic non-small cell lung cancer
28 April 2021 - Prescription Drug User Fee Act target action date set for 26 October 2021. ...
Posted by Michael Wonder on 28 Apr 2021
Rockwell Medical announces marketing approval of Triferic AVNU in Canada
27 March 2021 - Rockwell Medical today announced that Triferic AVNU (ferric pyrophosphate citrate injection) received a Notice of Compliance (marketing ...
Posted by Michael Wonder on 28 Apr 2021
Y-mAbs submits omburtamab marketing authorisation application to the EMA
27 April 2021 - Y-mAbs Therapeutics today announced that the Company has submitted its marketing authorisation application to the European Medicines ...
Posted by Michael Wonder on 27 Apr 2021
Medtronic receives FDA breakthrough designation for the Emprint ablation catheter kit
27 April 2021 - Minimally invasive option has potential to provide long-term management of lung malignancies while protecting lung function. ...
Posted by Michael Wonder on 27 Apr 2021
Sol-Gel Technologies provides update on FDA review of Epsolay
27 April 2021 - Sol-Gel Technologies today announced an update regarding the U.S. FDA approval process for Epsolay (benzoyl peroxide) ...
Posted by Michael Wonder on 27 Apr 2021
Enzyvant resubmits biologics licence application to FDA for RVT-802 for paediatric congenital athymia
27 April 2021 - Enzyvant today announced the resubmission of the biologics licence application to the U.S. FDA for RVT-802, ...
Posted by Michael Wonder on 27 Apr 2021
Fractyl announces FDA breakthrough device designation for Revita DMR in insulin treated type 2 diabetes
27 April 2021 - REVITA-T2Di trial is underway to evaluate the effectiveness of Revita DMR in improving glucose control while reducing ...
Posted by Michael Wonder on 27 Apr 2021
EMA grants accelerated assessment procedure for Nefecon for the treatment of IgA nephropathy
23 April 2021 - Calliditas Therapeutics today announced that its lead product candidate Nefecon, a novel oral formulation targeting down regulation ...
Posted by Michael Wonder on 27 Apr 2021
FDA guidance says sponsors should provide 'convincing' proof of concept data to support INDs for individualised medicine
26 April 2021 - Recent draft guidance from the US FDA addresses the non-clinical safety data to support investigational new ...
Posted by Michael Wonder on 27 Apr 2021
Glenmark’s Ryaltris nasal spray now approved in Europe for the first-line treatment of allergic rhinitis in patients over 12 years of age
26 April 2021 - This marks Glenmark’s first innovative product approval in the European Union. ...
Posted by Michael Wonder on 27 Apr 2021
Health Canada initiates the review of the rolling submission for the first Canadian based COVID-19 vaccine candidate
23 April 2021 - Medicago is pleased to announce that Health Canada received for review the first portion of Medicago’s ...
Posted by Michael Wonder on 27 Apr 2021
Reata announces FDA accepted for filing the NDA for bardoxolone for the treatment of patients with chronic kidney disease caused by Alport syndrome
26 April 2021 - Application assigned a PDUFA date of 25 February 2022. ...
Posted by Michael Wonder on 27 Apr 2021
Karyopharm announces European Medicines Agency's validation of its type II variation marketing authorisation application for Nexpovio (selinexor) in combination with Velcade (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma
26 April 2021 - EMA regulatory decision expected in the fourth quarter of 2021. ...
Posted by Michael Wonder on 27 Apr 2021
The European Union sues AstraZeneca over missing vaccine doses
26 April 2021 - The European Union has sued AstraZeneca over what the bloc has described as delays in shipping ...