Blog
RSS FeedPosted by Michael Wonder on 21 Sep 2022
The on- and off-ramps of oncology accelerated approval
21 September 2022 - To address ongoing concerns about the implementation of the FDA’s accelerated approval pathway in oncology, a ...
Posted by Michael Wonder on 21 Sep 2022
FDA approves selpercatinib for locally advanced or metastatic RET fusion positive solid tumours
21 September 2022 - Today, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly) for adult ...
Posted by Michael Wonder on 21 Sep 2022
argenx submits biologics license application to US Food and Drug Administration for subcutaneous efgartigimod for treatment of generalised myasthenia gravis
21 September 2022 - Submission package based on positive data from the Phase 3 ADAPT-SC trial demonstrating non-inferiority of subcutaneous efgartigimod ...
Posted by Michael Wonder on 21 Sep 2022
Tezspire approved in the EU for the treatment of severe asthma
21 September 2022 - First and only biologic approved in the EU in patients with severe asthma with no phenotype ...
Posted by Michael Wonder on 21 Sep 2022
Health Canada approves Takeda's Livtencity (maribavir) the first and only treatment for adults with post-transplant cytomegalovirus infection
20 September 2022 - Takeda Canada is pleased to announce that Health Canada has authorized (Notice of Compliance) Livtencity (maribavir) for ...
Posted by Michael Wonder on 20 Sep 2022
FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in paediatric patients with localised, non-metastatic solid tumours
20 September 2022 - Today, the FDA approved sodium thiosulphate (Pedmark, Fennec Pharmaceuticals) to reduce the risk of ototoxicity associated ...
Posted by Michael Wonder on 20 Sep 2022
UK regulator OKs Celltrion's Avastin biosimilar
19 September 2022 - Celltrion said that the UK's MHRA has approved Vegzelma, a biosimilar referencing Avastin (bevacizumab), to treat ...
Posted by Michael Wonder on 20 Sep 2022
Junshi Biosciences receives NMPA approval of sNDA for toripalimab in combination with chemotherapy as first-line treatment for advanced non-squamous non-small-cell lung cancer
20 September 2022 - Sixth approved indication of toripalimab in China, bringing more treatment options to patients with advanced non-small-cell ...
Posted by Michael Wonder on 20 Sep 2022
CHMP adopts positive opinion for Mycapssa for the treatment of acromegaly
16 September 2022 - Positive opinion based on MPOWERED Phase 3 trial. ...
Posted by Michael Wonder on 20 Sep 2022
Cidara Therapeutics announces FDA acceptance for priority review of new drug application for rezafungin for the treatment of candidemia and invasive candidiasis
20 September 2022 - Assigned PDUFA target action date of 22 March 2023. ...
Posted by Michael Wonder on 20 Sep 2022
EMA accepts MediWound’s application for extended indication for NexoBrid to treat paediatric patients with severe thermal burns
20 September 2022 - Upon approval, NexoBrid will serve as a safe and effective non-surgical treatment option in the EU for ...
Posted by Michael Wonder on 20 Sep 2022
Aurinia announces European Commission approval of Lupkynis (voclosporin) for the treatment of lupus nephritis
19 September 2022 - Lupkynis is the first oral medicine approved in both the US and Europe for the treatment of ...
Posted by Michael Wonder on 20 Sep 2022
Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19
20 September 2022 - Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase 3 treatment trial. ...
Posted by Michael Wonder on 20 Sep 2022
NICE recommends BeiGene’s Brukinsa (zanubrutinib) for patients with Waldenström’s macroglobulinaemia who have had at least one treatment
19 September 2022 - Brukinsa Is the first Bruton’s tyrosine kinase inhibitor recommended by NICE for routine use for Waldenström’s macroglobulinaemia. ...
Posted by Michael Wonder on 20 Sep 2022
European Medicine Agency accepts marketing authorisation applications for bimekizumab in psoriatic arthritis and axial spondyloarthritis
20 September 2022 - First regulatory submissions for bimekizumab in psoriatic arthritis and axial spondyloarthritis worldwide. ...