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RSS FeedPosted by Michael Wonder on 18 Aug 2025
RegenxBio announces FDA review extension of BLA for RGX-121 to treat patients with MPS II
18 August 2025 - RegenxBio today announced that the US FDA extended its review timeline of the biologics license application ...
Posted by Michael Wonder on 18 Aug 2025
Ifinatamab deruxtecan granted breakthrough therapy designation by US FDA for patients with pre-treated extensive stage small cell lung cancer
18 August 2025 - First breakthrough therapy designation for Daiichi Sankyo and Merck’s ifinatamab deruxtecan based on IDeate-Lung01 phase 2 ...
Posted by Michael Wonder on 18 Aug 2025
Stealth BioTherapeutics resubmits new drug application for elamipretide for the treatment of Barth syndrome
18 August 2025 - Stealth BioTherapeutics today announced the resubmission of a new drug application to the US FDA for Barth ...
Posted by Michael Wonder on 18 Aug 2025
European Commission grants approval of Ogsiveo
18 August 2025 - Merck KGaA announced today that the European Commission granted marketing authorisation for Ogisiveo (nirogacestat), an oral gamma ...
Posted by Michael Wonder on 17 Aug 2025
Wegovy approved in the US for the treatment of MASH
15 August 2025 - Novo Nordisk today announced that the US FDA has approved an additional indication for Wegovy (semaglutide ...
Posted by Michael Wonder on 16 Aug 2025
Vabysmo (faricimab injection) now publicly funded for macular oedema secondary to retinal vein occlusion and pre-filled syringe in Quebec
15 August 2025 - Vabysmo now covered across all three approved indications in the province, providing patients with a comprehensively ...
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
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 ...