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RSS FeedPosted 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. ...
Posted by Michael Wonder on 28 Apr 2025
First treatment against severe thyroid eye disease
25 April 2025 - Tepezza significantly improves symptoms for patients with moderate to severe thyroid eye disease ...
Posted by Michael Wonder on 27 Apr 2025
MHRA approves first UK treatment for Friedreich’s ataxia, omaveloxolone
23 April 2025 - The MHRA) has today approved omaveloxolone (Skyclarys), the first treatment for patients aged 16 and over, in ...
Posted by Michael Wonder on 24 Apr 2025
Latest update on US FDA BLA for Novavax's COVID-19 vaccine
23 April 2025 - We believe that our biologics license application is approvable based on conversations with the US FDA, ...
Posted by Michael Wonder on 24 Apr 2025
Sarclisa approved in Canada for patients with newly diagnosed multiple myeloma
22 April 2025 - This is the third indication for Sarclisa in Canada for the treatment of multiple myeloma. ...
Posted by Michael Wonder on 23 Apr 2025
Marstacimab approved to treat patients aged 12 years and above (weighing at least 35 kg) with haemophilia A or B
22 April 2025 - The MHRA has approved the medicine marstacimab (Hympavzi) to prevent or reduce bleeding in patients 12 years ...
Posted by Michael Wonder on 10 Apr 2025
Trastuzumab deruxtecan approved to treat adults with HER2-positive cancer that has spread or cannot be removed by surgery
9 April 2025 - The MHRA has today approved trastuzumab deruxtecan (Enhertu) to treat people with solid tumours that have ...
Posted by Michael Wonder on 09 Apr 2025
FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer
8 April 2025 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb ...
Posted by Michael Wonder on 02 Apr 2025
Valneva’s chikungunya vaccine Ixchiq now authorised in EU for adolescents aged 12 and above
1 April 2025 - With this extension, Ixchiq, the first vaccine against the chikungunya virus, is now available for administration ...
Posted by Michael Wonder on 02 Apr 2025
Rystiggo now approved for adults with generalised myasthenia gravis in Canada
2 April 2025 - The approval is supported by the pivotal Phase 3 MycarinG study in gMG, which demonstrated that treatment ...
Posted by Michael Wonder on 30 Mar 2025
World first as MHRA approves trofolastat for diagnostic imaging of prostate cancer in men
28 March 2025 - The MHRA has approved trofolastat (RoTecPSMA), the first prostate-specific membrane antigen (PSMA)-targeting product authorised for use with ...