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RSS FeedPosted by Michael Wonder on 05 Dec 2024
Health Canada approves Wegovy (semaglutide injection) to reduce the risk of non-fatal myocardial infarction
27 November 2024 - Wegovy is the first and only medication indicated for both chronic weight management and to reduce the ...
Posted by Michael Wonder on 05 Dec 2024
Applied Therapeutics receives complete response letter from US FDA regarding new drug application for govorestat for classic galactosaemia
27 November 2024 - Applied Therapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 05 Dec 2024
GSK’s fully liquid Menveo meningococcal vaccine approved by European Commission
27 November 2024 - New fully liquid presentation means reconstitution is not needed before use. ...
Posted by Michael Wonder on 05 Dec 2024
European Commission approves BeiGene’s Tevimbra for first-line treatment of advanced/metastatic oesophageal squamous cell carcinoma and gastric or gastro-oesophageal junction cancer
27 November 2024 - New indications based on two Phase 3 studies demonstrating statistically significant overall survival benefit for patients ...
Posted by Michael Wonder on 04 Dec 2024
Fedratinib dihydrochloride monohydrate for the treatment of adults with disease-related splenomegaly or symptoms in myelofibrosis
20 November 2024 - NICE has published final evidence-based recommendations on the use of fedratinib dihydrochloride monohydrate (Inrebic) for the ...
Posted by Michael Wonder on 04 Dec 2024
Novartis Kisqali receives European Commission approval in a broad population of patients with HR positive/HER2 negative early breast cancer at high risk of recurrence
27 November 2024 - Approval is based on Phase 3 NATALEE data showing Kisqali (ribociclib) plus adjuvant endocrine therapy demonstrated clinically ...
Posted by Michael Wonder on 03 Dec 2024
Shorla Oncology announces FDA approval of Imkeldi (imatinib) oral solution, an oral liquid for the treatment of certain forms of leukaemia and other cancers
25 November 2024 - Imkeldi marks Shorla Oncology’s fourth FDA Approval. ...
Posted by Michael Wonder on 02 Dec 2024
US FDA approves AOP Health’s Rapiblyk (landiolol) for atrial fibrillation and atrial flutter in the critical care setting
27 November 2024 - AOP Orphan Pharmaceuticals announced that the US FDA has granted regulatory approval for Rapiblyk (landiolol) in the ...
Posted by Michael Wonder on 01 Dec 2024
Amneal resubmits DHE auto-injector new drug application and receives US FDA approval of exenatide, its first generic injectable GLP-1 agonist
21 November 2024 - Potential first and only DHE auto-injector for tough-to-treat migraines and cluster headaches. ...
Posted by Michael Wonder on 01 Dec 2024
Attruby (acoramidis), a near complete TTR stabiliser (≥90%), approved by FDA to reduce cardiovascular death and cardiovascular related hospitalisation in ATTR-CM patients
22 November 2024 - Attruby is the first and only approved product with a label specifying near complete stabilisation of TTR. ...
Posted by Michael Wonder on 30 Nov 2024
Health Canada authorises Carvykti (ciltacabtagene autoleucel) for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
21 November 2024 - Authorisation is based on results from the Phase 3 CARTITUDE-4 (MMY3002) study, which showed treatment with ...
Posted by Michael Wonder on 30 Nov 2024
FDA approves updated drug labelling for fludarabine phosphate under Project Renewal
19 November 2024 - Today, the FDA approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection, Sandoz) under Project ...
Posted by Michael Wonder on 28 Nov 2024
US FDA approves FoundationOne Liquid CDx as a companion diagnostic for Tepmetko (tepotinib) to identify patients with MET exon 14 skipping alterations in non-small cell lung cancer
18 November 2024 - FoundationOne Liquid CDx is the first FDA approved companion diagnostic to identify patients who may be ...
Posted by Michael Wonder on 28 Nov 2024
European Commission approves Pfizer’s Hympavzi (marstacimab) for the treatment of adults and adolescents with severe haemophilia A or B without inhibitors
20 November 2024 - In the EU, Hympavzi is the first once weekly subcutaneous treatment approved for eligible people living with ...
Posted by Michael Wonder on 27 Nov 2024
UCB receives US FDA approval for Bimzelx (bimekizumab-bkzx) as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa
20 November 2024 - Approval is supported by data from the two Phase 3 studies, BE HEARD I and BE HEARD ...