Blog
RSS FeedPosted by Michael Wonder on 26 May 2023
Janssen seeks European Commission approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of patients with relapsed and refractory multiple myeloma
25 May 2023 - Application to the EMA is supported by data from the Phase 3 CARTITUDE-4 study, which evaluated the ...
Posted by Michael Wonder on 25 May 2023
Sandoz marketing authorisation applications for proposed biosimilar denosumab accepted by EMA
25 May 2023 - Submissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and ...
Posted by Michael Wonder on 24 May 2023
Phathom Pharmaceuticals resubmits erosive GERD new drug application to FDA
23 May 2023 - Anticipated FDA action date in Q4, 2023; if approved, combined launch for erosive gastro-oesophageal reflux disease and H. ...
Posted by Michael Wonder on 24 May 2023
Sarepta Therapeutics announces update on regulatory review of SRP-9001
24 May 2023 - New regulatory action date is 22 June 2023. ...
Posted by Michael Wonder on 23 May 2023
Pierre Fabre announces start of EU marketing authorization application procedure for vibegron in overactive bladder
22 May 2023 - Following the exclusive licensing agreement with Urovant Sciences, Pierre Fabre announced today the start of the ...
Posted by Michael Wonder on 22 May 2023
Satsuma Pharmaceuticals announces FDA acceptance of 505(b)(2) NDA for STS101, a novel and investigational dihydroergotamine nasal powder product for the acute treatment of migraine
18 May 2023 - January 2024 PDUFA date expected. ...
Posted by Michael Wonder on 20 May 2023
EMA validates marketing authorisation application for efanesoctocog alfa for treatment of haemophilia A
19 May 2023 - Sobi today announced that the EMA has accepted and validated a marketing authorisation application for efanesoctocog alfa, ...
Posted by Michael Wonder on 19 May 2023
Bausch + Lomb and Novaliq announce FDA approval of Miebo (perfluorohexyloctane ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease
18 May 2023 - Miebo is the first and only prescription eye drop approved for dry eye disease that directly targets ...
Posted by Michael Wonder on 18 May 2023
Elevar Therapeutics submits new drug application to FDA for combination of rivoceranib and camrelizumab as first-line treatment option for unresectable hepatocellular carcinoma
17 May 2023 - Elevar Therapeutics today announced it submitted a new drug application to the US FDA for its investigational ...
Posted by Michael Wonder on 17 May 2023
US FDA grants priority review of TAK-755 for the treatment of congenital thrombotic thrombocytopenic purpura
16 May 2023 - FDA has granted TAK-755 priority review and rare paediatric disease designation, as well as fast track designation ...
Posted by Michael Wonder on 16 May 2023
U.S. Food and Drug Administration issues complete response letter for Byondis' trastuzumab duocarmazine
15 May 2023 - Complete response letter outlines FDA's request for additional information. ...
Posted by Michael Wonder on 16 May 2023
Health Canada accepts new drug submission for lecanemab as treatment for early Alzheimer’s disease
15 May 2023 - Eisai and Biogen announced today that Health Canada has accepted a new drug submission for lecanemab for ...
Posted by Michael Wonder on 13 May 2023
Tetra Bio-Pharma cancels new drug submission to Health Canada
11 May 2023 - Tetra Bio-Pharma today announced it has cancelled its new drug submission to Health Canada, without prejudice ...
Posted by Michael Wonder on 11 May 2023
FDA approval, clinical trial evidence, efficacy, epidemiology, and price for non-orphan and ultra-rare, rare, and common orphan cancer drug indications: cross sectional analysis
9 May 2023 - The objective of this study was to analyse the US FDA approval, trials, unmet needs, benefit, and ...
Posted by Michael Wonder on 11 May 2023
Servier receives European Commission approval of Tibsovo (ivosidenib tablets) in IDH1 mutated acute myeloid leukaemia and IDH1 mutated cholangiocarcinoma
10 May 2023 - Marketing Authorization granted for Tibsovo as the first and only approved IDH1 targeted therapy in Europe. ...