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RSS FeedPosted 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 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14 August 2025 - In final draft guidance published today we've confirmed that we’re unable to recommend cerliponase alfa (Brineura; BioMarin) ...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 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 ...
Posted by Michael Wonder on 11 Aug 2025
Trump’s trade war is not the only threat to cheap PBS medicines
10 August 2025 - Australia’s health system is rightly celebrated for its universal access and cost effectiveness, but its outdated assessment ...
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
Labor ‘very concerned’ by Trump pharma threat
7 August 2025 - The Albanese Government says it is “very concerned” after Donald Trump’s latest tariff threat on a key ...
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 ...