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RSS FeedPosted by Michael Wonder on 17 Jan 2025
Atara Biotherapeutics provides regulatory and business update on Ebvallo (tabelecleucel)
16 January 2025 - Atara received FDA complete response letter solely related to inspection findings at third party manufacturer. ...
Posted by Michael Wonder on 16 Jan 2025
Foresee Pharmaceuticals announces the PDUFA goal date for the 3 month version of Camcevi is 29 August 2025
13 January 2025 - Foresee Pharmaceuticals announces that the US FDA issued a Day 74 letter. ...
Posted by Michael Wonder on 16 Jan 2025
ImmunityBio provides regulatory update on global submission for Anktiva + BCG in BCG unresponsive non-muscle invasive bladder cancer with carcinoma in situ in Europe and United Kingdom
15 January 2025 - ImmunityBio responding to requests for information from both Agencies and the potential for approval in European Union ...
Posted by Michael Wonder on 15 Jan 2025
New drug application initiated with US FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer
15 January 2025 - Application accepted for US FDA Real-Time Oncology Review based on Phase 2b SunRISe-1 study showing highest ...
Posted by Michael Wonder on 15 Jan 2025
Acadia Pharmaceuticals submits marketing authorisation application to the EMA for trofinetide for the treatment of Rett syndrome
14 January 2025 - Filing marks company’s first marketing authorisation application in Europe. ...
Posted by Michael Wonder on 14 Jan 2025
FDA accepts Leqembi (lecanemab-irmb) biologics license application for subcutaneous maintenance dosing for the treatment of early Alzheimer’s disease
13 January 2025 - Eisai and Biogen announced today that the US FDA has accepted Eisai’s biologics license application for lecanemab-irmb ...
Posted by Michael Wonder on 13 Jan 2025
Datopotamab deruxtecan granted priority review in the US for patients with previously treated advanced EGFR mutated non-small cell lung cancer
13 January 2025 - Application based on TROPION-Lung05 Phase 2 trial and supported by data from TROPION-Lung01 Phase 3 and ...
Posted by Michael Wonder on 13 Jan 2025
GSK’s Shingrix new pre-filled syringe presentation accepted for review by US FDA
10 January 2025 - An FDA decision on the application is expected by 20 June 2025. ...
Posted by Michael Wonder on 13 Jan 2025
Bayer submits application to US FDA and to China’s CDE for new indication of finerenone for patients with common form of heart failure with high unmet medical need
10 January 2025 - Regulatory submissions are based on positive data from the Phase 3 FINEARTS-HF study recently presented at ESC ...
Posted by Michael Wonder on 12 Jan 2025
Important milestone for Biotest: biologics license application for fibrinogen submitted to the US FDA
9 January 2025 - The biologics license application for Biotest’s fibrinogen has been submitted to the US FDA. ...
Posted by Michael Wonder on 10 Jan 2025
Nipocalimab granted US FDA priority review for the treatment of generalized myasthenia gravis
9 January 2024 - Biologics license application acceptance supported by results from the Phase 3 Vivacity-MG3 study. ...
Posted by Michael Wonder on 10 Jan 2025
FDA accepts Agios’ supplemental new drug application for Pyrukynd (mitapivat) in adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
8 January 2025 - Agios Pharmaceuticals today announced that the US FDA accepted the company’s supplemental new drug application for Pyrukynd ...
Posted by Michael Wonder on 09 Jan 2025
US FDA confirms class 1 resubmission of the supplemental new drug application for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy
8 January 2025 - Astellas today announced the US FDA accepted the revised supplemental new drug application for Izervay (avacincaptad ...
Posted by Michael Wonder on 08 Jan 2025
US FDA granted priority review to Dizal's sunvozertinib new drug application
7 January 2025 - Sunvozertinib's new drug application was submitted based on the multinational pivotal WU-KONG1 Part B study, the ...
Posted by Michael Wonder on 07 Jan 2025
EMA commences review of donidalorsen in hereditary angioedema
6 January 2025 - Otsuka announces that the EMA has accepted for review the marketing authorisation application for the hereditary ...