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RSS FeedPosted by Michael Wonder on 11 Sep 2023
Aquestive Therapeutics receives FDA acceptance of new drug application for Libervant (diazepam) buccal film in paediatric patients and assignment of PDUFA date
11 September 2023 - PDUFA target goal date set for 28 April 2024. ...
Posted by Michael Wonder on 11 Sep 2023
Verona Pharma announces the US FDA has accepted the new drug application filing for ensifentrine for the maintenance treatment of COPD
11 September 2023 - PDUFA target action date of 26 June 2024. ...
Posted by Michael Wonder on 07 Sep 2023
US FDA accepts marketing authorisation application for immunoglobulin Yimmugo
7 September 2023 - First marketing authorization application for a Biotest product from new "Biotest Next Level" production facility for the ...
Posted by Michael Wonder on 06 Sep 2023
FDA accepts application for Genentech’s crovalimab for the treatment of PNH, a rare life-threatening blood condition
6 September 2023 - Acceptance based on the Phase III COMMODORE 2 study, which demonstrated crovalimab achieved disease control and was ...
Posted by Michael Wonder on 06 Sep 2023
X4 Pharmaceuticals announces submission of new drug application to US FDA for mavorixafor in WHIM syndrome
5 September 2023 - Submission supported by positive results from global, pivotal 4WHIM Phase 3 clinical trial. ...
Posted by Michael Wonder on 01 Sep 2023
Hugel resubmits BLA for its botulinum toxin, Letybo to the US FDA
1 September 2023 - Expected to obtain the US FDA's approval in the first quarter of 2024. ...
Posted by Michael Wonder on 31 Aug 2023
Zealand Pharma announces designation of priority review by the US FDA for dasiglucagon in congenital hyperinsulinism
30 August 2023 - To ensure the most efficient regulatory process, the review by the US FDA will be conducted in ...
Posted by Michael Wonder on 29 Aug 2023
Janssen submits supplemental new drug application to the US FDA seeking full approval of Balversa (erdafitinib) for the treatment of patients with locally advanced or metastatic urothelial carcinoma and selected fibroblast growth factor receptor gene alterations
28 August 2023 - Submission based on confirmatory data from cohort 1 of the Phase 3 THOR study, which showed ...
Posted by Michael Wonder on 28 Aug 2023
AbbVie submits regulatory applications to FDA and EMA for risankizumab (Skyrizi) in ulcerative colitis
29 August 2023 - Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical ...
Posted by Michael Wonder on 25 Aug 2023
Janssen submits supplemental biologics license application to the US FDA seeking approval of Rybrevant (amivantamab-vmjw) in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic EGFR exon 20 insertion mutation positive non-small cell lung cancer
25 August 2023 - Application is supported by data from PAPILLON, the first randomised Phase 3 study to show clinically meaningful ...
Posted by Michael Wonder on 23 Aug 2023
Geron announces PDUFA date for imetelstat NDA in lower risk MDS
22 August 2023 - Geron Corporationtoday announced that the US FDA has assigned a standard review and a PDUFA action date ...
Posted by Michael Wonder on 23 Aug 2023
FDA grants priority review for Xtandi in non-metastatic castration sensitive prostate cancer with high risk biochemical recurrence
23 August 2023 - If approved, Xtandi would become the first and only novel hormone therapy approved in this earlier ...
Posted by Michael Wonder on 21 Aug 2023
Geron announces FDA acceptance of new drug application for imetelstat for the treatment of lower risk MDS
21 August 2023 - Geron Corporation today announced that the US FDA has accepted the filing of Geron’s new drug application ...
Posted by Michael Wonder on 18 Aug 2023
FDA grants priority review for full approval of Tarpeyo for the treatment of IgA nephropathy
18 August 2023 - Calliditas Therapeutics today announced that the US FDA has accepted the submission for the supplemental new ...
Posted by Michael Wonder on 16 Aug 2023
Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib tablets) in the treatment of IDH1 mutated relapsed or refractory myelodysplastic syndromes
15 August 2023 - Submission supported by comprehensive clinical data package, including updated results that demonstrate durable remissions and an ...