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RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 16 Aug 2025
MHRA approves teplizumab to delay progression of type 1 diabetes
14 August 2025 - The MHRA has today approved teplizumab (Tzield) to delay the onset of stage 3 type 1 ...
Posted by Michael Wonder on 16 Aug 2025
FDA approves first immunotherapy for recurrent respiratory papillomatosis
14 August 2025 - Today, the US FDA approved Papzimeos (zopapogene imadenovec-drba), a first of its kind non-replicating adenoviral vector-based immunotherapy ...
Posted by Michael Wonder on 16 Aug 2025
Tonix Pharmaceuticals announces FDA approval of Tonmya (cyclobenzaprine hydrochloride sublingual tablets) for the treatment of fibromyalgia
15 August 2025 - Commercial availability of Tonmya is expected in the fourth quarter. ...
Posted by Michael Wonder on 16 Aug 2025
Halda Therapeutics receives FDA fast track designation for HLD-0915 for the treatment of metastatic castration-resistant prostate cancer
14 August 2025 - Halda Therapeutics today announced that the US FDA granted fast track designation to HLD-0915, the company’s ...
Posted by Michael Wonder on 15 Aug 2025
Thermo Fisher receives FDA approval for NGS based companion diagnostic for new non-small cell lung cancer treatment
11 August 2025 - Thermo Fisher Scientific has received approval from the US FDA for its Oncomine Dx Target Test as ...
Posted by Michael Wonder on 14 Aug 2025
Final decision on cerliponase alfa for Batten disease treatment confirmed
14 August 2025 - In final draft guidance published today we've confirmed that we’re unable to recommend cerliponase alfa (Brineura; BioMarin) ...
Posted 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
New and expanded PBS listings for endometrial cancer, neuroblastoma, Parkinson's disease and melanoma
11 August 2025 - Australians with Parkinson’s disease, neuroblastoma, endometrial cancer, cystic fibrosis and melanoma will have access to new ...
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
SMC - August 2025 decisions
11 August 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 11 Aug 2025
PHARMAC to update access and supply of COVID-19 treatments
11 August 2025 - Pharmac will simplify the criteria for people accessing COVID-19 anti-viral medicines and will align the funding ...