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RSS FeedPosted by Michael Wonder on 06 May 2025
Teva and Alvotech announce FDA approval of interchangeability for Selarsdi (ustekinumab-aekn) with Stelara (ustekinumab)
5 May 2025 - The US FDA has approved Selarsdi (ustekinumab-aekn) as interchangeable with the reference biologic Stelara (ustekinumab) in all ...
Posted by Michael Wonder on 03 May 2025
FDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity
2 May 2025 - The FDA filing is based on the results of the Phase 3 OASIS 4 trial that evaluated ...
Posted by Michael Wonder on 03 May 2025
Vimkunya vaccine approved to prevent disease caused by the chikungunya virus in people 12 years of age and older
1 May 2025 - The MHRA has today approved a vaccine (Vimkunya) used to prevent disease caused by the chikungunya virus ...
Posted by Michael Wonder on 02 May 2025
Satsuma Pharmaceuticals announces US FDA approval for Atzumi (dihydroergotamine) nasal powder for the acute treatment of migraine
30 April 2025 - Atzumi is the first and only product utilising the SMART (Simple MucoAdhesive Release Technology) platform which combines ...
Posted by Michael Wonder on 30 Apr 2025
Johnson & Johnson receives FDA approval for Imaavy (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis
30 April 2025 - First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and paediatric generalised myasthenia gravis. ...
Posted by Michael Wonder on 30 Apr 2025
US FDA approves Zevaskyn (prademagene zamikeracel), the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa
29 April 2025 - Rare paediatric disease priority review voucher granted by FDA. ...
Posted by Michael Wonder on 29 Apr 2025
Rinvoq (upadacitinib) receives US FDA approval for giant cell arteritis
29 April 2025 - Rinvoq (upadacitinib) is now the first and only oral Janus kinase inhibitor approved for the treatment of ...
Posted by Michael Wonder on 29 Apr 2025
Fixed-duration Calquence-based regimens recommended for approval in the EU by CHMP for first-line chronic lymphocytic leukaemia
29 April 2025 - Recommendation based on AMPLIFY Phase III trial which showed Calquence combinations demonstrated statistically significant and clinically ...
Posted by Michael Wonder on 29 Apr 2025
Eton Pharmaceuticals announces submission of NDA for ET-600 (desmopressin oral solution)
28 April 2025 - Expected 10 month review; commercial preparations underway for a potential Q1 2026 launch. ...
Posted by Michael Wonder on 29 Apr 2025
Health Canada approves Iqirvo as a first-in-class dual-peroxisome proliferator-activated receptor treatment for primary biliary cholangitis
28 April 2025 - Iqirvo (elafibranor) is the first new medicine approved in nearly a decade for the treatment of ...
Posted by Michael Wonder on 28 Apr 2025
Telix provides regulatory update on TLX101-CDx
28 April 2028 - Telix Pharmaceuticals today announces that it has received a complete response letter from the US FDA ...
Posted by Michael Wonder on 28 Apr 2025
Lynozyfic (linvoseltamab) approved in the European Union for the treatment of relapsed/refractory multiple myeloma
28 April 2025 - Regeneron Pharmaceuticals today announced that the European Commission has granted conditional marketing approval of Lynozyfic (linvoseltamab) to ...
Posted by Michael Wonder on 28 Apr 2025
Vertex receives CHMP positive opinion for Alyftrek, a new once-daily CFTR modulator for the treatment of cystic fibrosis
28 April 2025 - In head-to-head clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior on ppFEV1 and superior compared to Kaftrio (ivacaftor/tezacaftor/elexacaftor) at ...
Posted by Michael Wonder on 28 Apr 2025
Jazz Pharmaceuticals receives CHMP positive opinion for zanidatamab for the treatment of advanced HER2 positive biliary tract cancer
25 April 2025 - Jazz Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion recommending the ...
Posted by Michael Wonder on 28 Apr 2025
New treatment against Duchenne muscular dystrophy
25 April 2025 - Duvyzat can be used in a wide patient population from the age of six. ...