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RSS FeedPosted by Michael Wonder on 20 Aug 2025
PTC Therapeutics receives complete response letter for vatiquinone NDA
19 August 2025 - PTC Therapeutics announced today that the US FDA has issued a complete response letter related to ...
Posted by Michael Wonder on 19 Aug 2025
Pfizer Canada and BioNTech receive Health Canada approval of LP.8.1 variant adapted COVID-19 vaccine
18 August 2025 - LP.8.1 variant adapted COVID-19 vaccine Cominaty is now authorised in Canada for individuals 6 months of age ...
Posted by Michael Wonder on 19 Aug 2025
Iovance’s Amtagvi (lifileucel) receives Health Canada approval for advanced melanoma
18 August 2025 - Iovance Biotherapeutics today announced Health Canada has issued a Notice of Compliance with Conditions for Amtagvi ...
Posted by Michael Wonder on 19 Aug 2025
Valneva’s chikungunya vaccine Ixchiq now authorised in Canada for individuals aged 12 and plder
18 August 2025 - Valneva today announced that Health Canada has granted marketing authorisation for its single dose vaccine, Ixchiq, ...
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
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 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14 August 2025 - In final draft guidance published today we've confirmed that we’re unable to recommend cerliponase alfa (Brineura; BioMarin) ...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 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 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 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
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 ...