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RSS FeedPosted by Michael Wonder on 28 Oct 2024
Astellas provides update on marketing authorisation application for avacincaptad pegol in the European Union
28 October 2024 - Astellas today announced the company's decision to withdraw its marketing authorisation application from the EMA for ...
Posted by Michael Wonder on 26 Oct 2024
Lenz Therapeutics announces FDA acceptance of new drug application for LNZ100 for the treatment of presbyopia
21 October 2024 - FDA sets PDUFA target date of 8 August 2025. ...
Posted 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 17 Oct 2024
Alnylam submits regulatory application to the EMA for vutrisiran for the treatment of ATTR amyloidosis with cardiomyopathy
16 October 2024 - Type II variation submission based on the positive HELIOS-B Phase 3 trial in which vutrisiran significantly reduced ...
Posted by Michael Wonder on 17 Oct 2024
Bayer submits EU marketing authorization application for elinzanetant to treat moderate to severe vasomotor symptoms
15 October 2024 - EMA submission is based on data from Phase 3 OASIS development program for elinzanetant. ...
Posted by Michael Wonder on 17 Oct 2024
Experts label TGA’s decision to not register Alzheimer’s drug ‘extremely disappointing’
16 October 2024 - A drug that could hold the key to delaying symptoms of devastating Alzheimer’s disease will not be ...
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 15 Oct 2024
Bayer submits application for third indication of darolutamide in the EU
14 October 2024 - Submission is based on positive results from the pivotal Phase 3 ARANOTE trial, which showed that darolutamide ...
Posted by Michael Wonder on 11 Oct 2024
Johnson & Johnson submits application to the EMA for Darzalex (daratumumab) SC based quadruplet regimen for newly diagnosed multiple myeloma patients
10 October 2024 - Submission supported by data from the Phase 3 CEPHEUS study for the treatment of patients with newly ...
Posted by Michael Wonder on 11 Oct 2024
EMA confirms acceptance of marketing application for AVT03, a proposed biosimilar to Prolia and Xgeva
10 October 2024 - Alvotech announced today that the EMA has accepted a marketing authorisation application for AVT03, a proposed biosimilar ...