Blog
RSS FeedPosted by Michael Wonder on 04 Mar 2024
Tebentafusp in uveal melanoma: indication of a considerable additional benefit
1 March 2024 - Patients with inoperable or metastatic uveal melanoma survive longer with the new therapy than with other therapy ...
Posted by Michael Wonder on 04 Mar 2024
Hugel receives US FDA approval for its botulinum toxin Letybo
3 March 2024 - Hugel becomes the first and only Korean company that have market approvals in all three major aesthetic ...
Posted by Michael Wonder on 02 Mar 2024
Patisiran sodium in hereditary transthyretin amyloidosis: less benefit than vutrisiran
1 March 2024 - In 2023, IQWiG found an additional benefit of vutrisiran compared to patisiran sodium based on a study. ...
Posted by Michael Wonder on 01 Mar 2024
FDA approves amivantamab-vmjw for EGFR exon 20 insertion mutated non-small cell lung cancer indications
1 March 2024 - Today, the FDA approved amivantamab-vmjw (Rybrevant, Janssen) with carboplatin and pemetrexed for the first-line treatment of ...
Posted by Michael Wonder on 01 Mar 2024
More rare conditions considered for newborn bloodspot screening and new treatment option for spinal muscular atrophy
29 February 2024 - On Rare Disease Day, the Albanese Government has announced two more rare genetic conditions have been ...
Posted by Michael Wonder on 28 Feb 2024
AB Science announces that Health Canada has issued a notice of non-compliance-withdrawal for masitinib in ALS
26 February 2024 - AB Science today announces that Health Canada has issued a notice of non-compliance-withdrawal regarding its new ...
Posted by Michael Wonder on 27 Feb 2024
Theratechnologies receives refusal to file letter for Trogarzo intramuscular method of administration sBLA from FDA
27 February 2024 - Theratechnologies today announced that the US FDA has issued a refusal to file letter regarding the Company’s ...
Posted by Michael Wonder on 27 Feb 2024
Minerva Neurosciences receives complete response letter from FDA for new drug application for roluperidone for the treatment of negative symptoms in patients with schizophrenia
27 February 2024 - Minerva Neurosciences announced today that the US FDA has issued a complete response letter to the ...
Posted by Michael Wonder on 27 Feb 2024
Etrasimod arginine for the treatment of patients with moderate to severe active ulcerative colitis
27 February 2024 - NICE has published final evidence-based recommendations on the use of etrasimod arginine (Velsipity) for the treatment ...
Posted by Michael Wonder on 26 Feb 2024
Voydeya recommended for approval in the EU by CHMP as add-on treatment to ravulizumab or eculizumab for adults with PNH who have residual haemolytic anaemia
26 February 2024 - Recommendation of first in class, oral, factor D inhibitor based on ALPHA Phase 3 trial results. ...
Posted by Michael Wonder on 26 Feb 2024
CSL Vifor and Travere Therapeutics announce sparsentan receives positive CHMP opinion for the treatment of IgA nephropathy
23 February 2024 - Positive CHMP opinion is based on pivotal Phase 3 PROTECT study results. ...
Posted by Michael Wonder on 26 Feb 2024
Highlights from the 19-22 February 2024 CHMP meeting
23 February 2024 - The EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting. ...
Posted by Michael Wonder on 26 Feb 2024
Alvotech and Teva announce US approval of Simlandi (adalimumab-ryvk) injection, the first interchangeable high concentration, citrate free biosimilar to Humira
23 February 2024 - Simlandi is the first citrate free, high concentration biosimilar to be designated interchangeable to Humira in the ...
Posted by Michael Wonder on 24 Feb 2024
Vertex receives CHMP positive opinion for Kalydeco for the treatment of infants with cystic fibrosis ages 1 month and older
23 February 2024 - If approved, Kalydeco will be the first and only medicine approved in Europe to treat the underlying ...
Posted by Michael Wonder on 24 Feb 2024
Venatorx and Melinta provide update on status of US new drug application for cefepime-taniborbactam
23 February 2024 - No clinical safety or efficacy issues identified. ...