Blog
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 20 Feb 2025
Fast track granted by FDA for NNZ-2591 in Pitt Hopkins syndrome
19 February 2025 - : Neuren Pharmaceuticals today announced that the US FDA has granted fast track designation for NNZ-2591 ...
Posted by Michael Wonder on 20 Feb 2025
Boehringer’s zongertinib receives priority review from US FDA for the treatment of HER2 (ERBB2)-mutant advanced non-small cell lung cancer
19 February 2025 - The application for this investigational treatment is based on positive results from the Phase Ib Beamion LUNG-1, ...
Posted by Michael Wonder on 20 Feb 2025
Clarity receives US FDA fast track designation for the treatment of metastatic castration resistant prostate cancer patients with copper Cu 67 SAR-bisPSMA
19 February 2025 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for ...
Posted by Michael Wonder on 19 Feb 2025
European Commission approves Biocon Biologics’ ustekinumab biosimilar
18 February 2025 - Biocon announced today that the European Commission granted marketing authorisation in the European Union for Yesintek, ...
Posted by Michael Wonder on 19 Feb 2025
Selpercatinib for the treatment of patients with advanced RET fusion positive non-small-cell lung cancer
19 February 2025 - NICE has published final evidence-based recommendations on the use of selpercatinib (Retsevmo) for the treatment of ...
Posted by Michael Wonder on 19 Feb 2025
Durvalumab in combination with etoposide phosphate and either carboplatin or cisplatin for the first-line treatment of patients with extensive-stage small-cell lung cancer
19 February 2025 - NICE has published final evidence-based recommendations on the use of durvalumab (Imfinzi) in combination with etoposide ...
Posted by Michael Wonder on 19 Feb 2025
Galderma’s Nemluvio (nemolizumab) granted marketing authorisation in the United Kingdom and Switzerland for moderate to severe atopic dermatitis and prurigo nodularis
18 February 2025 - These are the first approvals of nemolizumab from countries within the Access Consortium framework, with regulatory review ...
Posted by Michael Wonder on 19 Feb 2025
Ultragenyx announces FDA acceptance and priority review of the biologics license application for UX111 AAV gene therapy to treat Sanfilippo syndrome type A
18 February 2025 - FDA decision expected by 18 August 2025. ...
Posted by Michael Wonder on 18 Feb 2025
Welireg (belzutifan) receives first European Commission approval for two indications
18 February 2025 - Welireg is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union ...
Posted by Michael Wonder on 18 Feb 2025
Petosemtamab granted breakthrough therapy designation by the US FDA for first-line PD-L1 positive head and neck squamous cell carcinoma
18 February 2025 - This marks the second breakthrough therapy designation for petosemtamab in head and neck squamous cell carcinoma. ...
Posted by Michael Wonder on 18 Feb 2025
US FDA accepts Gilead’s new drug applications for twice yearly lenacapavir for HIV prevention under priority review
18 February 2025 - FDA to review applications under priority review, with a PDUFA date of 19 June 2025. ...
Posted by Michael Wonder on 18 Feb 2025
Chimerix announces FDA acceptance and priority review of new drug application for dordaviprone as treatment for recurrent H3 K27M mutant diffuse glioma
18 February 2025 - PDUFA target action date of 18 August 2025. ...
Posted by Michael Wonder on 18 Feb 2025
Novartis’ Kisqali granted MHRA approval to treat early breast cancer patients
5 February 2025 - The medicine is already approved in the UK to treat advanced cases of the disease. ...
Posted by Michael Wonder on 18 Feb 2025
Dupixent (dupilumab) sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid
18 February 2025 - If approved, Dupixent would be the first and only targeted medicine to treat bullous pemphigoid in the US; ...
Posted by Michael Wonder on 18 Feb 2025
Nemolizumab approved to treat prurigo nodularis and atopic dermatitis for patients in the UK
17 February 2025 - This national approval was granted after an Access Consortium new active substance work-sharing initiative (NASWSI) procedure. ...