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RSS FeedPosted by Michael Wonder on 06 Oct 2022
US FDA accepts Takeda’s supplemental biologics license application for use of Takzyro (lanadelumab-flyo) to prevent hereditary angioedema attacks in children 2 years of age and older
5 October 2022 - Filing is based on data from Phase 3 SPRING study in paediatric patients 2 to <12 years ...
Posted by Michael Wonder on 29 Sep 2022
BioMarin resubmits biologics license application for valoctocogene roxaparvovec AAV gene therapy for severe haemophilia A to the FDA
29 September 2022 - BLA includes substantial body of data from pivotal Phase 3 and on-going Phase 1/2 studies. ...
Posted by Michael Wonder on 28 Sep 2022
Citius Pharmaceuticals submits biologics license application to the US Food and Drug Administration for denileukin diftitox for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma
28 September 2022 - Citius Pharmaceuticals today announced that the Company has submitted a biologics license application to the US FDA ...
Posted by Michael Wonder on 28 Sep 2022
Pharming announces US FDA acceptance for priority review of its new drug application for leniolisib
28 September 2022 - The FDA has assigned a PDUFA goal date of 29 March 2023 for the NDA submission based ...
Posted by Michael Wonder on 27 Sep 2022
Blue Earth Diagnostics announces FDA acceptance of new drug application for 18F-rhPSMA-7.3, a radiohybrid prostate specific membrane antigen targeted PET imaging agent for prostate cancer
27 September 2022 - Blue Earth Diagnostics today announced that the US FDA has accepted its filing for a new ...
Posted by Michael Wonder on 26 Sep 2022
Better Therapeutics submits de novo request to US FDA for BT-001 investigational prescription digital therapy for type 2 diabetes
22 September 2022 - Submission follows completion of first in class trial demonstrating significant improvements in A1c reduction with investigational therapy ...
Posted by Michael Wonder on 26 Sep 2022
Botanix submission of FDA new drug application for sofpironium bromide
26 September 2022 - Submission follows the results from the Cardigan (Phase 3) clinical studies which were positive and highly ...
Posted by Michael Wonder on 21 Sep 2022
argenx submits biologics license application to US Food and Drug Administration for subcutaneous efgartigimod for treatment of generalised myasthenia gravis
21 September 2022 - Submission package based on positive data from the Phase 3 ADAPT-SC trial demonstrating non-inferiority of subcutaneous efgartigimod ...
Posted by Michael Wonder on 20 Sep 2022
Cidara Therapeutics announces FDA acceptance for priority review of new drug application for rezafungin for the treatment of candidemia and invasive candidiasis
20 September 2022 - Assigned PDUFA target action date of 22 March 2023. ...
Posted by Michael Wonder on 19 Sep 2022
Seagen announces Tukysa (tucatinib) in combination with trastuzumab granted priority review by FDA for previously treated HER2 positive metastatic colorectal cancer
19 September 2022 - FDA has set action date of 19 January 2023 . ...
Posted by Michael Wonder on 19 Sep 2022
Ascendis Pharma submits TransCon PTH new drug application to the US FDA for adult patients with hypoparathyroidism
31 August 2022 - European MAA on track for Q4, 2022 submission. ...
Posted by Michael Wonder on 13 Sep 2022
Clovis Oncology submits applications for Rubraca label expansion in the US and European Union as first-line maintenance treatment in women with advanced ovarian cancer
13 September 2022 - Submissions based on data from the Phase 3 ATHENA trial evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) presented ...
Posted by Michael Wonder on 13 Sep 2022
BWXT Medical submits Tc 99m generator new drug application to FDA
13 September 2022 - Company highlights growing nuclear medicine product portfolio and future opportunities in therapeutic radioisotopes. ...
Posted by Michael Wonder on 13 Sep 2022
Otsuka and Lundbeck announce U.S. FDA acceptance of new drug application for aripiprazole 2 month, ready to use, long-acting injectable to treat schizophrenia and bipolar I disorder in adults
13 September 2022 - Filing is supported by a 32 week bridging trial in which aripiprazole 2 month showed comparable effectiveness ...
Posted by Michael Wonder on 12 Sep 2022
Acadia Pharmaceuticals announces trofinetide new drug application for the treatment of Rett syndrome has been accepted for filing and review by US FDA
12 September 2022 - Prescription Drug User Fee Act action date set for 12 March 2023. ...