Blog
RSS FeedPosted by Michael Wonder on 03 Jul 2024
China’s National Medical Products Administration Approves Xtandi (enzalutamide) in metastatic hormone sensitive prostate cancer
2 July 2024 - Approval marks Xtandi’s third indication for advanced prostate cancer in China. ...
Posted by Michael Wonder on 03 Jul 2024
Johnson & Johnson receives approval from US FDA and European Commission for Sirturo (bedaquiline)
2 July 2024 - Johnson & Johnson announced today that the US FDA has issued traditional approval for Sirturo (bedaquiline) ...
Posted by Michael Wonder on 03 Jul 2024
Inozyme Pharma announces FDA fast track designation for INZ-701 in ABCC6 deficiency
2 July 2024 - Inozyme Pharma today announced that the US FDA has granted fast track designation to INZ-701 for ...
Posted by Michael Wonder on 03 Jul 2024
Osimertinib mesylate for the adjuvant treatment of patients with EGFR mutation positive non-small-cell lung cancer after complete tumour resection
27 June 2024 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...
Posted by Michael Wonder on 03 Jul 2024
Kye Pharmaceuticals announces the availability of Quillivant ER chewable tablets for the treatment of children with ADHD
2 July 2024 - Quillivant ER chewable tablets are the first and only extended release chewable methylphenidate tablets approved in Canada. ...
Posted by Michael Wonder on 03 Jul 2024
Dupixent (dupilumab) approved in the European Union as the first ever targeted therapy for patients with COPD
3 July 2024 - First in world approval of Dupixent for adults with uncontrolled COPD with raised blood eosinophils based on ...
Posted by Michael Wonder on 03 Jul 2024
Sobi initiates rolling biologics license application to FDA for SEL-212 for the potential treatment of chronic refractory gout
2 July 2024 - Sobi today announced the initiation of a rolling biologics license application to the US FDA for SEL-212. ...
Posted by Michael Wonder on 03 Jul 2024
"99mTc-maraciclatide" granted FDA fast track designation for the diagnosis of superficial peritoneal endometriosis
2 July 2024 - Serac Healthcare announced today that the US FDA has granted fast track designation to 99mTc-maraciclatide as a ...
Posted by Michael Wonder on 02 Jul 2024
Multiple myeloma treatments available to more people
2 July 2024 - PHARMAC is making more treatment options available for people with multiple myeloma and other blood disorders. ...
Posted by Michael Wonder on 02 Jul 2024
FDA approves treatment for adults with Alzheimer’s disease
2 July 2024 - The US FDA has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. ...
Posted by Michael Wonder on 02 Jul 2024
ICER publishes evidence report on treatment for anaemia in myelodysplastic syndrome
2 July 2024 - There are significant uncertainties regarding long term efficacy and safety of imetelstat; treatment would achieve common ...
Posted by Michael Wonder on 02 Jul 2024
FDA breakthrough therapy designation reduced late-stage drug development time
1 July 2024 - The FDA’s breakthrough therapy designation program was created to increase patient access to safe and effective therapies ...
Posted by Michael Wonder on 02 Jul 2024
Altos Biologics files for approval of aflibercept biosimilar
1 July 2024 - Alteogen announced on 1 July that its subsidiary, Altos Biologics submitted a marketing authorisation application to ...
Posted by Michael Wonder on 02 Jul 2024
Standardisation of practice on publication of indications in Swiss Public Assessment Report
1 July 2024 - In order to standardise practice, Swissmedic will in future publish both the proposed and approved indications in ...
Posted by Michael Wonder on 02 Jul 2024
Longboard Pharmaceuticals receives breakthrough therapy designation for bexicaserin
1 July 2024 - Longboard Pharmaceuticals today announced that the FDA has granted breakthrough therapy designation for its investigational drug ...