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RSS FeedPosted by Michael Wonder on 19 Aug 2024
EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
19 August 2024 - Application based on the TRANSCEND FL trial in which Breyanzi showed deep and durable responses and a ...
Posted by Michael Wonder on 19 Aug 2024
Enhertu type II variation application validated by EMA for patients with HER2 low or HER2 ultralow metastatic breast cancer following at least one endocrine therapy
19 August 2024 - Submission based on DESTINY-Breast06 Phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated ...
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 16 Aug 2024
EMA confirms acceptance of marketing application for AVT06, a proposed biosimilar to Eylea (aflibercept)
15 August 2024 - The approvals process is anticipated to be completed in the third quarter of 2025. ...
Posted by Michael Wonder on 16 Aug 2024
KalVista announces validation of marketing authorisation application by the EMA for sebetralstat for hereditary angioedema
15 August 2024 - KalVista Pharmaceuticals today announced that the EMA has validated the submission of a marketing authorisation application for ...
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
Marius Pharmaceuticals submits Kyzatrex (testosterone undecanoate) capsules for approval to Health Canada
30 July 2024 - Marius Pharmaceuticals is pleased to announce the submission of its new drug submission for Kyzatrex (testosterone ...
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 01 Aug 2024
BioNet’s recombinant pertussis vaccine submitted to EMA
31 July 2024 - BioNet Europe has announced the submission of a centralised marketing authorisation application to the EMA for its ...