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RSS FeedPosted by Michael Wonder on 23 Oct 2024
FDA accepts new drug application and grants priority review for TLX101-CDx (Pixclara) brain cancer imaging agent
24 October 2024 - Telix Pharmaceuticals today announces that the US FDA has accepted the new drug application for TLX101-CDx (Pixclara), ...
Posted by Michael Wonder on 22 Oct 2024
Camurus provides regulatory update on the US NDA for CAM2029 in acromegaly
22 October 2024 - The FDA issues a complete response letter for CAM2029 pending FDA’s assessment of responses from a third ...
Posted by Michael Wonder on 21 Oct 2024
Elevar Therapeutics announces FDA acceptance of new drug application resubmission for rivoceranib in combination with camrelizumab as a first-line systemic treatment for unresectable hepatocellular carcinoma
21 October 2024 - FDA sets a PDUFA target action date of 20 March 2025. ...
Posted by Michael Wonder on 20 Oct 2024
Intercept provides regulatory update regarding sNDA for Ocaliva
17 October 2024 - Intercept Pharmaceuticals today announced that the US FDA has informed the Company that it is continuing its ...
Posted by Michael Wonder on 17 Oct 2024
Tonix Pharmaceuticals announces submission of the TNX-102 SL new drug application for fibromyalgia to the US FDA
16 October 2024 - New drug application based on two Phase 3 studies of TNX-102 SL in fibromyalgia with statistically significant ...
Posted by Michael Wonder on 17 Oct 2024
Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents
16 October 2024 - Application supported by positive results from pivotal Phase 3 EAGLE-2 and EAGLE-3 trials. ...
Posted by Michael Wonder on 16 Oct 2024
UroGen announces FDA acceptance of its new drug application for UGN-102
15 October 2024 - PDUFA goal date set for 13 June 2025. ...
Posted by Michael Wonder on 10 Oct 2024
Alnylam submits supplemental new drug application to the US FDA for vutrisiran for the treatment of transthyretin amyloidosis with cardiomyopathy
9 October 2024 - Priority review voucher utilised to accelerate review period. ...
Posted by Michael Wonder on 10 Oct 2024
Capricor Therapeutics announces initiation of rolling submission of biologics license application with US FDA for deramiocel for the treatment of Duchenne muscular dystrophy
9 October 2024 - Company plans to complete rolling BLA submission by end of 2024; application may be eligible for ...
Posted by Michael Wonder on 09 Oct 2024
Zealand Pharma provides US regulatory update on dasiglucagon in congenital hyperinsulinism
9 October 2024 - The re-inspection of the facility was completed in August/September 2024 for which a new inspection classification is ...
Posted by Michael Wonder on 09 Oct 2024
Teva Prolia (denosumab) biosimilar candidate is accepted for review by US FDA and EU EMA
8 October 2024 - TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of ...
Posted by Michael Wonder on 08 Oct 2024
Indivior's Sublocade rapid induction/alternative injection site prior approval supplement receives FDA priority review
7 October 2024 - Indivior today announced the prior approval supplement for Sublocade (buprenorphine extended release) injection submitted by Indivior has ...
Posted by Michael Wonder on 08 Oct 2024
Neuvivo seeks FDA approval for its breakthrough ALS treatment NP001
7 October 2024 - Neuvivo today announced it submitted a new drug application to the US FDA for NP001 (sodium chlorite ...
Posted by Michael Wonder on 03 Oct 2024
Calquence granted priority review in the US for patients with untreated mantle cell lymphoma
3 October 2024 - Submission to be reviewed under Project Orbis. ...
Posted by Michael Wonder on 02 Oct 2024
Johnson & Johnson files for US FDA approval of Darzalex Faspro based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned
30 September 2024 - Results from CEPHEUS study highlight Darzalex Faspro quadruplet regimen as a potential standard of care in ...