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RSS FeedPosted by Michael Wonder on 04 Apr 2024
FDA accepts supplemental biologics license applications for Bimzelx (bimekizumab-bkzx) for moderate to severe hidradenitis suppurativa and additional 2 mL device presentations
4 April 2024 - Application in moderate to severe hidradenitis suppurativa based on results from two Phase 3 studies where ...
Posted by Michael Wonder on 04 Apr 2024
Rocket Pharmaceuticals announces EMA acceptance of RP-L102 marketing authorisation application for the treatment of Fanconi anaemia
2 April 2024 - Positive, previously disclosed results from the global Phase 1/2 trial demonstrated genetic and phenotypic correction combined ...
Posted by Michael Wonder on 03 Apr 2024
Zanidatamab biologics license application for previously treated HER2 positive metastatic biliary tract cancer completed
2 April 2024 - Zymeworks is pleased to announce, along with our partners Jazz Pharmaceuticals, completion of the rolling submission of ...
Posted by Michael Wonder on 03 Apr 2024
Autolus Therapeutics announces acceptance of marketing authorisation application by the EMA for obecabtagene autoleucel for patients with relapsed/refractory adult B-cell acute lymphoblastic leukaemia
2 April 2024 - Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALL. ...
Posted by Michael Wonder on 03 Apr 2024
Vertex announces new drug submission for exagamglogene autotemcel (exa-cel) has been accepted for priority review by Health Canada for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
1 April 2024 - Exa-cel is the first CRISPR-based gene-edited therapy to be submitted for Health Canada review. ...
Posted by Michael Wonder on 02 Apr 2024
Datopotamab deruxtecan biologics license application accepted in the US for patients with previously treated metastatic HR positive, HER2 negative breast cancer
2 April 2024 - Application based on results from the TROPION-Breast01 Phase 3 trial. ...
Posted by Michael Wonder on 01 Apr 2024
Eisai completes submission of Leqembi (lecanemab-irmb) supplemental biologics license application for IV maintenance dosing for the treatment of early Alzheimer’s disease to the US FDA
1 April 2024 - Eisai and Biogen announced today that Eisai submitted to the US FDA a supplemental biologics license ...
Posted by Michael Wonder on 01 Apr 2024
US FDA accepts Astellas’ supplemental new drug application for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy
1 April 2024 - Target action date set for 19 November 2024. ...
Posted by Michael Wonder on 29 Mar 2024
PTC announces submission of sepiapterin MAA for treatment of PKU to EMA
28 March 2024 - First marketing authorisation submission for sepiapterin with additional global submissions to follow in 2024. ...
Posted by Michael Wonder on 28 Mar 2024
China's National Medical Products Administration accepts Astellas and Pfizer's supplemental biologics license application for enfortumab vedotin with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
28 March 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival vs platinum-containing ...
Posted by Michael Wonder on 27 Mar 2024
Norgine receives positive CHMP opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia
26 March 2024 - Norgine today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
Posted by Michael Wonder on 27 Mar 2024
Syndax announces FDA priority review of NDA for revumenib for the treatment of relapsed/refractory KMT2Ar acute leukaemia
26 March 2024 - PDUFA action date set for 26 September 2024. ...
Posted by Michael Wonder on 21 Mar 2024
Health Canada accepts for review new drug submission for tofersen for treatment of rare, genetic form of ALS
19 March 2024 - Health Canada regulatory decision on tofersen new drug submission expected in early 2025. ...
Posted by Michael Wonder on 20 Mar 2024
US FDA approves Idorsia’s once-daily Tryvio (aprocitentan) – the first and only endothelin receptor antagonist for the treatment of high blood pressure not adequately controlled in combination with other antihypertensives
20 March 2024 - Idorsia plans to make Tryvio available to the millions of patients in the US who are not ...
Posted by Michael Wonder on 19 Mar 2024
Citius Pharmaceuticals announces FDA acceptance of the BLA resubmission of Lymphir (denileukin diftitox) for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma
18 March 2024 - FDA assigns Prescription Drug User Fee Act target action date of 13 August 2024 ...