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RSS FeedPosted by Michael Wonder on 14 Aug 2025
Health Canada approves Keytruda for patients with resectable locally advanced head & neck squamous cell carcinoma tumours that are PD-L1 (CPS) positive as neo-adjuvant treatment, continued as adjuvant treatment combined with radiotherapy with or without cisplatin then as monotherapy
13 August 2025 - Approval is based on KEYNOTE-689 Phase III clinical trial results. ...
Posted by Michael Wonder on 13 Aug 2025
Creative Medical Technology secures FDA fast track designation for CELZ-201-DDT - advancing breakthrough therapy for chronic lower back pain
13 August 2025 - Creative Medical Technology Holdings today announced that the US FDA has granted fast track designation to its ...
Posted by Michael Wonder on 13 Aug 2025
AAVantgarde Bio announces FDA fast track designation for AAVB-039 for the treatment of Stargardt disease
12 August 2025 - AAVantgarde Bio today announced that the US FDA has granted fast track designation for AAVB-039, the company’s ...
Posted by Michael Wonder on 12 Aug 2025
FDA approves Brinsupri (brensocatib) as the first and only treatment for non-cystic fibrosis bronchiectasis, a serious, chronic lung disease
12 August 2025 - Brinsupri, a first in class DPP1 inhibitor targeting neutrophilic inflammation, is available by prescription through a comprehensive ...
Posted by Michael Wonder on 12 Aug 2025
NRx Pharmaceuticals granted FDA fast track designation for NRX-100 for suicidal ideation in patients with depression, including bipolar depression
11 August 2025 - NRx Pharmaceuticals today announced US FDA has granted fast track designation to NRX-100 for the treatment of ...
Posted by Michael Wonder on 11 Aug 2025
Gepotidacin accepted for priority review by the US FDA for the oral treatment of uncomplicated urogenital gonorrhoea
11 August 2025 - 11 December assigned as PDUFA goal date for FDA decision ...
Posted by Michael Wonder on 11 Aug 2025
Lantheus announces FDA acceptance of NDA for new formulation for market leading PSMA PET imaging agent
6 August 2025 - PDUFA date set for March 6, 2026 ...
Posted by Michael Wonder on 10 Aug 2025
America’s drug regulator is in turmoil
10 August 2025 - The already fraught oversight of rare disease treatments is becoming politicised. ...
Posted by Michael Wonder on 09 Aug 2025
Imfinzi approved in Canada as first and only peri-operative immunotherapy for muscle invasive bladder cancer
6 August 2025 - Health Canada has granted a Notice of Compliance for Imfinzi (durvalumab) for the treatment of patients ...
Posted by Michael Wonder on 09 Aug 2025
International study on authorisation times confirms Swissmedic's competitiveness
6 August 2025 - Latest CIRS study rates Swissmedic's authorisation procedures for human medicinal products with new active substances as internationally ...
Posted by Michael Wonder on 09 Aug 2025
Medicines for chronic illnesses soon accessible before European authorisation
7 August 2025 - The scheme will be launched on 1 January 2026 and is expected to provide access to ...
Posted by Michael Wonder on 09 Aug 2025
Health Canada has authorised CSL's Andembry (garadacimab) as once monthly treatment for hereditary angioedema
8 August 2025 - CSL today announced that Health Canada has granted a marketing authorisation for Andembry (garadacimab) for routine ...
Posted by Michael Wonder on 09 Aug 2025
Arvinas announces FDA acceptance of the new drug application for vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer
8 August 2025 - Filing based on pivotal Phase 3 VERITAC-2 clinical trial demonstrating statistically significant and clinically meaningful improvement in ...
Posted by Michael Wonder on 08 Aug 2025
FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations
8 August 2025 - Today, the FDA granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals), a kinase inhibitor, for ...
Posted by Michael Wonder on 08 Aug 2025
FDA approves expanded indication for Avtozma (tocilizumab-anoh) intravenous formulation in cytokine release syndrome
6 August 2025 - Approval of Avtozma (tocilizumab-anoh) intravenous infusion expands label to include treatment of adults and paediatric patients aged ...