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RSS FeedPosted by Michael Wonder on 31 Oct 2025
Enhertu approved in Canada as the first and only HER2 directed therapy for patients with HR positive HER2 low or HER2 ultra low metastatic breast cancer, following disease progression after one or more endocrine therapies
29 October 2025 - Based on the DESTINY-Breast06 Phase 3 trial results demonstrating statistically significant and clinically meaningful progression-free survival ...
Posted by Michael Wonder on 30 Oct 2025
FDA moves to accelerate biosimilar development and lower drug costs
29 October 2025 - The US FDA today announced significant action to make it faster and less costly to develop ...
Posted by Michael Wonder on 30 Oct 2025
FDA accepts BioMarin’s Palynziq (pegvaliase-pqpz) supplemental biologics license application for priority review to expand use to adolescents aged 12-17 with phenylketonuria
29 October 2025 - Application based on positive results from Phase 3 PEGASUS study, which demonstrated statistically significant blood phenylalanine lowering ...
Posted by Michael Wonder on 29 Oct 2025
Enigma Biomedical USA announces FDA acceptance of new drug application for florquinitau F-18 (MK-6240), a tau PET Alzheimer’s disease radiodiagnostic
28 October 2025 - Enigma Biomedical today announced that the FDA has accepted a new drug application for MK-6240 (florquinitau F-18), ...
Posted by Michael Wonder on 29 Oct 2025
Alphamab Oncology announces biparatopic HER2 targeting ADC JSKN003 was granted fast track designation by FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
28 October 2025 - Alphamab Oncology announced that the biparatopic HER2-targeting antibody drug conjugate JSKN003 has been granted fast track designation ...
Posted by Michael Wonder on 28 Oct 2025
Koselugo approved in the EU for plexiform neurofibromas in adults with neurofibromatosis type 1
28 August 2025 - Approval based on KOMET Phase 3 trial results which showed 20% objective response rate in tumour ...
Posted by Michael Wonder on 28 Oct 2025
Cellectar Biosciences receives rare paediatric disease designation from US FDA for iopofosine I 131 in relapsed or refractory paediatric high-grade glioma
27 October 2025 - Cellectar Biosciences today announced the US FDA has granted rare paediatric drug designation for iopofosine I ...
Posted by Michael Wonder on 27 Oct 2025
US FDA approves updated indication for Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (WHO Group 1 pulmonary hypertension) based on Phase 3 ZENITH study
27 October 2025 - Merck today announced that the US FDA has approved an update to the US product label based ...
Posted by Michael Wonder on 27 Oct 2025
Lilly's Omvoh (mirikizumab-mrkz) approved by US FDA as a single-injection maintenance regimen in adults with ulcerative colitis
27 October 2025 - Omvoh now offers patients a simplified maintenance experience with one monthly injection, replacing the previous two injection ...
Posted by Michael Wonder on 27 Oct 2025
Flaws in the FDA’s new priority voucher program
25 October 2025 - A new FDA program is being promoted as a tool to facilitate the development and approval of ...
Posted by Michael Wonder on 27 Oct 2025
Health Canada grants authorisation for Leqembi (lecanemab) for the treatment of early Alzheimer’s disease
26 October 2025 - Eisai and Biogen announced today that Health Canada has issued a notice of compliance with conditions for ...
Posted by Michael Wonder on 25 Oct 2025
Receipt of complete response ketter from US FDA for investigational ND0612
23 October 2025 - Mitsubishi Tanabe Pharma today announced that the US FDA has issued a complete response letter for ...
Posted by Michael Wonder on 25 Oct 2025
Revolution Medicines awarded voucher for daraxonrasib (RMC-6236) under FDA Commissioner's National Priority Voucher Pilot Program
16 October 2025 - Revolution Medicines today announced that the US FDA has granted a non-transferrable voucher for daraxonrasib (RMC-6236), ...
Posted by Michael Wonder on 25 Oct 2025
Agitated Solutions receives fast track designation for investigational drug ASI-02
23 October 2025 - ASI-02 is a novel contrast agent for cardiac bubble studies. ...
Posted by Michael Wonder on 24 Oct 2025
Bayer’s Lynkuet (elinzanetant) approved in the US for treatment of moderate to severe vasomotor symptoms due to menopause
24 October 2025 - This approval is supported by data from the Phase 3 OASIS clinical program evaluating Lynkuet (elinzanetant) for ...