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RSS FeedPosted by Michael Wonder on 27 Aug 2024
Rhythm Pharmaceuticals announces FDA acceptance for priority review of supplemental new drug application for Imcivree (setmelanotide) in patients as young as 2 years old
26 August 2024 - FDA sets PDUFA goal date of 26 December 2024. ...
Posted by Michael Wonder on 21 Aug 2024
Bristol Myers Squibb receives US Food and Drug Administration sBLA acceptance for first-line treatment of unresectable hepatocellular carcinoma
21 August 2024 - The US FDA assigned a target action date of 21 April 2025. ...
Posted by Michael Wonder on 16 Aug 2024
US FDA accepts for priority review Deciphera’s new drug application for vimseltinib for the treatment of patients with tenosynovial giant cell tumour
15 August 2024 - The US FDA has assigned a target action date of 17 February 2025. ...
Posted by Michael Wonder on 15 Aug 2024
UroGen submits completed UGN-102 NDA seeking approval as the first FDA approved treatment for low grade intermediate risk non-muscle invasive bladder cancer
14 August 2024 - UroGen Pharma today announced the successful completion of its new drug application submission for investigational drug UGN-102, ...
Posted by Michael Wonder on 13 Aug 2024
Bavarian Nordic announces FDA acceptance and priority review of the BLA for its Chikungunya vaccine
13 August 2024 - PDUFA target action date of 14 February 2025. ...
Posted by Michael Wonder on 13 Aug 2024
Lenz Therapeutics announces submission of new drug application to US FDA for LNZ100 for the treatment of presbyopia
12 August 2024 - Lenz Therapeutics today announced that the Company has submitted a new drug application to US FDA for ...
Posted by Michael Wonder on 07 Aug 2024
George Medicines files new drug application with FDA for novel low dose triple combination for treatment of hypertension following successful international Phase 3 development program
6 August 2024 - Two international Phase 3 clinical trials for the treatment of hypertension, versus dual therapy and placebo, met ...
Posted by Michael Wonder on 05 Aug 2024
FDA submission to expand minimum age for Xenoview
1 August 2024 - Polarean Imaging announces that it has submitted a new drug application supplement to the US FDA to ...
Posted by Michael Wonder on 03 Aug 2024
FDA has accepted a BLA for bentracimab, the first and only ticagrelor reversal agent, for filing and priority review
2 August 2024 - SFJ Pharmaceuticals, sponsor of the bentracimab biologics license application, and SERB Pharmaceuticals (SERB), who acquired exclusive ...
Posted by Michael Wonder on 03 Aug 2024
Bayer submits new drug application to US FDA for elinzanetant for the treatment of moderate to severe vasomotor symptoms associated with menopause
1 August 2024 - The new drug application includes data from the Phase 3 studies OASIS 1, 2 and 3 ...
Posted by Michael Wonder on 02 Aug 2024
Supernus resubmits NDA for SPN-830 apomorphine infusion device
1 August 2024 - Supernus Pharmaceuticals today announced it has resubmitted its new drug application for its apomorphine infusion device ...
Posted by Michael Wonder on 31 Jul 2024
PTC Therapeutics announces sepiapterin NDA submission to FDA
30 July 2024 - PTC Therapeutics announced today the submission of the sepiapterin new drug application to the US FDA. ...
Posted by Michael Wonder on 30 Jul 2024
FDA accepts Telix NDA for new prostate cancer imaging agent
23 July 2024 - Telix today announces that the US FDA has accepted the filing of its new drug application for ...
Posted by Michael Wonder on 30 Jul 2024
Vertex announces FDA acceptance of new drug application for suzetrigine for the treatment of moderate to severe acute pain
30 July 2024 - FDA grants priority review and assigns a PDUFA target action date of 30 January 2025. ...
Posted by Michael Wonder on 30 Jul 2024
Novartis Scemblix granted FDA priority review for the treatment of adults with newly diagnosed CML
29 July 2024 - Priority review based on ASC4FIRST Phase 3 study with Scemblix data first to show significantly improved molecular ...