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RSS FeedPosted by Michael Wonder on 16 Feb 2024
Japan first in the world to approve Dupixent for chronic spontaneous urticaria
16 February 2024 - Approval based primarily on results from Phase 3 trial showing Dupixent significantly reduced itch compared to ...
Posted by Michael Wonder on 15 Feb 2024
FDA approves tepotinib for metastatic non-small-cell lung cancer
15 February 2024 - Today, the FDA granted traditional approval to tepotinib (Tepmetko, EMD Serono) for adult patients with metastatic ...
Posted by Michael Wonder on 15 Feb 2024
Elrexfio is authorised by Health Canada for adults with relapsed or refractory multiple myeloma in Canada
13 February 2024 - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance with conditions to Elrexfio ...
Posted by Michael Wonder on 14 Feb 2024
FDA approves first medication to treat severe frostbite
14 February 2024 - The US FDA approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk ...
Posted by Michael Wonder on 14 Feb 2024
Health Canada approves Keytruda in combination with trastuzumab and chemotherapy, as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma whose tumours express PD-L1
12 February 2024 - Approval is based on the Phase 3 KEYNOTE-811 Trial. ...
Posted by Michael Wonder on 13 Feb 2024
FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma
13 February 2024 - Today, the FDA approved irinotecan liposome (Onivyde, Ipsen) with oxaliplatin, fluorouracil, and leucovorin, for the first-line ...
Posted by Michael Wonder on 13 Feb 2024
SMC - February 2024 decisions
12 February 2024 - The SMC, which advises on newly-licensed medicines for use by NHSScotland, has today published advice on ...
Posted by Michael Wonder on 13 Feb 2024
European Commission approves first CRISPR/Cas9 gene-edited therapy, Casgevy (exagamglogene autotemcel), for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
13 February 2024 - Over 8,000 patients 12 years of age and older with severe sickle cell disease or transfusion-dependent ...
Posted by Michael Wonder on 13 Feb 2024
Biogen received European Commission approval for Skyclarys (omaveloxolone), the first therapy to treat Friedreich’s ataxia
12 February 2024 - Biogen announced the European Commission has authorised Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia in ...
Posted by Michael Wonder on 12 Feb 2024
FDA approves Takeda’s Eohilia (budesonide oral suspension), the first and only oral treatment in the US for eosinophilic oesophagitis
12 February 2024 - 12 weeks of treatment with Eohilia may address significant unmet needs of patients 11 years of age ...
Posted by Michael Wonder on 12 Feb 2024
MHRA approvals for Comirnaty (Pfizer/BioNTech) and Nuvaxovid (Novavax) COVID-19 vaccines
10 February 2024 - Approval of a change to the licence of Comirnaty COVID-19 vaccine will enable thawing and re-labelling of ...
Posted by Michael Wonder on 08 Feb 2024
Crovalimab approved in China as the first country for the treatment of paroxysmal nocturnal haemoglobinuria
8 February 2024 - Crovalimab, the fifth Chugai originated global drug, approved for the first time in the world. ...
Posted by Michael Wonder on 08 Feb 2024
Health Canada approves Brukinsa (zanubrutinib) for the treatment of relapsed or refractory follicular lymphoma
7 February 2024 - Brukinsa is the first and only BTK inhibitor approved for follicular lymphoma in Canada. ...
Posted by Michael Wonder on 07 Feb 2024
Olaparib in combination with abiraterone acetate for the treatment of patients with hormone relapsed metastatic prostate cancer
7 February 2024 - NICE has published final evidence-based recommendations on the use of olaparib (Lynparza) in combination with abiraterone ...
Posted by Michael Wonder on 07 Feb 2024
Belumosudil mesylate for the treatment of patients with chronic graft versus host disease
7 February 2024 - NICE has published final evidence-based recommendations on the use of belumosudil mesylate (Rezurock) for the treatment ...