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RSS FeedPosted by Michael Wonder on 20 Nov 2021
COVID-19 vaccine weekly safety report (18 November 2021)
18 November 2021 - To 14 November 2021, about 23.4 million doses of Comirnaty (Pfizer) have been administered in Australia. ...
Posted by Michael Wonder on 20 Nov 2021
Reata Pharmaceuticals receives fast track designation from the FDA for omaveloxolone for the treatment of Friedreich’s ataxia
18 November 2021 - Reata Pharmaceuticals today announced the U.S. FDA has granted fast track designation for omaveloxolone for the ...
Posted by Michael Wonder on 20 Nov 2021
FDA approves Merck’s Keytruda (pembrolizumab) as adjuvant therapy for certain patients with renal cell carcinoma following surgery
18 November 2021 - Keytruda is the first immunotherapy approved for the adjuvant treatment of these patients with renal cell carcinoma. ...
Posted by Michael Wonder on 20 Nov 2021
FDA approves first drug to improve growth in children with most common form of dwarfism
19 November 2021 - Today, the U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five ...
Posted by Michael Wonder on 17 Nov 2021
Zentalis Pharmaceuticals announces fast track designation granted by the U.S. FDA to ZN-c3 for the treatment of uterine serous carcinoma
17 November 2021 - Zentalis Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to ZN-c3, the Company’s ...
Posted by Michael Wonder on 17 Nov 2021
Lokelma granted fast track designation in the US to reduce cardiovascular outcomes in patients on chronic haemodialysis with hyperkalaemia
17 November 2021 - AstraZeneca has been granted fast track designation in the United States for the development of Lokelma (sodium ...
Posted by Michael Wonder on 17 Nov 2021
AbbVie expands immunology portfolio in the European Union with the European Commission approval of Skyrizi (risankizumab) for the treatment of adults with active psoriatic arthritis
17 November 2021 - Approval supported by data from two Phase 3 studies evaluating Skyrizi in psoriatic arthritis patients, KEEPsAKE-1 and ...
Posted by Michael Wonder on 17 Nov 2021
European Commission approves Nucala (mepolizumab) in three additional eosinophil-driven diseases
17 November 2021 - Approval for the first targeted treatment for eosinophilic granulomatosis with polyangiitis and the first anti-IL-5 biologic treatment ...
Posted by Michael Wonder on 17 Nov 2021
EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid
17 November 2021 - EMA has started evaluating an application for conditional marketing authorisation for Novavax’s COVID-19 vaccine, Nuvaxovid (also known ...
Posted by Michael Wonder on 16 Nov 2021
Pre-approval and post-approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: a comparison with standard approved cancer drugs
15 November 2021 - Cancer drugs are increasingly approved through expedited regulatory pathways including the European conditional marketing authorisation. ...
Posted by Michael Wonder on 16 Nov 2021
Viatris and Biocon Biologics announce launch of interchangeable Semglee (insulin glargine-yfgn) injection and insulin glargine (insulin glargine-yfgn) injection
16 November 2021 - Branded and unbranded versions of the first-ever interchangeable biosimilar in the U.S. provide more affordable options for ...
Posted by Michael Wonder on 16 Nov 2021
Pfizer seeks emergency use authorisation for novel COVID-19 oral antiviral candidate
16 November 2021 - If approved or authorised, Paxlovid (PF-07321332; ritonavir) would be the first oral antiviral of its kind, a ...
Posted by Michael Wonder on 16 Nov 2021
FDA authorises marketing of virtual reality system for chronic pain reduction
16 November 2021 - The U.S. FDA today authorized marketing of EaseVRx, a prescription-use immersive virtual reality system that uses cognitive ...
Posted by Michael Wonder on 16 Nov 2021
Nexviazyme (avalglucosidase alfa for injection) is now approved in Canada for patients with late-onset Pompe disease (acid α-glucosidase deficiency)
15 November 2021 - Nexviazyme (avalglucosidase alfa for injection) is now approved in Canada for the long-term treatment of patients older ...
Posted by Michael Wonder on 16 Nov 2021
CARsgen announces CAR T-cell product candidate CT041 granted PRIME eligibility by the EMA
15 November 2021 - CARsgen Therapeutics today announced that the EMA has granted Priority Medicines (PRIME) eligibility to CT041 for the ...