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RSS FeedPosted by Michael Wonder on 14 Jan 2025
Lokon Pharma receives FDA fast track designation for LOAd703 for the treatment of pancreatic cancer
10 January 2025 - Lokon Pharma today announced that the US FDA has granted fast track designation for the company´s product ...
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
FDA grants fast track designation to Spinogenix's SPG601 for treatment of Fragile X syndrome, a common inherited form of autism
13 January 2025 - -- Spinogenix today announced that the US FDA has granted fast track designation to SPG601 for the ...
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
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
Vanda's letter to FDA Commissioner highlights faulty gastroparesis NDA review
8 January 2025 - Vanda Pharmaceuticals letter to FDA Commissioner highlights faulty gastroparesis NDA review. ...
Posted by Michael Wonder on 12 Jan 2025
BridgeBio Oncology Therapeutics granted US FDA fast track designation for BBO-8520 for KRASG12C mutated metastatic non-small cell lung cancer
9 January 2025 - The US FDA has granted fast track designation to BBO-8520 for the treatment of adult patients with ...
Posted by Michael Wonder on 12 Jan 2025
Mersana Therapeutics announces additional FDA fast track designation granted to emiltatug ledadotin (XMT-1660)
10 January 2025 - Mersana Therapeutics today announced the US FDA recently granted an additional fast track designation to XMT-1660. ...
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
PureTech receives FDA fast track designation for LYT-200 in acute myeloid leukaemia
9 January 2024 - Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of ...
Posted by Michael Wonder on 09 Jan 2025
CDER brings many safe and effective therapies to patients and consumers in 2024
8 January 2024 - Each year, the US FSA’s Center for Drug Evaluation and Research (CDER) evaluates and, as appropriate, approves ...
Posted by Michael Wonder on 09 Jan 2025
Johnson & Johnson’s posdinemab and tau active immunotherapy receive US FDA fast track designations for the treatment of Alzheimer’s disease
8 January 2025 - Building on decades of the Company’s Alzheimer’s research, two differentiated investigational therapies aim to slow pathological tau ...
Posted by Michael Wonder on 09 Jan 2025
Denali Therapeutics announces US FDA breakthrough therapy designation granted to tividenofusp alfa for the treatment of Hunter syndrome
8 January 2025 - Denali Therapeutics today announced that the US FDA has granted breakthrough therapy designation for tividenofusp alfa (DNL310) ...
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 ...