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RSS FeedPosted by Michael Wonder on 08 Apr 2024
Carvykti is the first and only BCMA targeted treatment approved by the US FDA for patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy
5 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with Carvykti ...
Posted by Michael Wonder on 05 Apr 2024
FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2 positive solid tumours
5 April 2024 - Today, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with ...
Posted by Michael Wonder on 05 Apr 2024
US FDA approves Bristol Myers Squibb and 2seventy bio’s Abecma for triple-class exposed relapsed or refractory multiple myeloma after two prior lines of therapy
5 April 2024 - Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial, with a 51% ...
Posted by Michael Wonder on 04 Apr 2024
Vanda Pharmaceuticals' Fanapt (iloperidone) receives US FDA approval for the acute treatment of bipolar I disorder
2 April 2024 - Fanapt treatment is now available to adult patients for the acute treatment of manic or mixed episodes ...
Posted by Michael Wonder on 03 Apr 2024
FDA approves new antibiotic for three different uses
3 April 2024 - Today, the US FDA approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with ...
Posted by Michael Wonder on 01 Apr 2024
Voydeya approved in the US as add-on therapy to ravulizumab or eculizumab for treatment of extravascular haemolysis in adults with the rare disease PNH
1 April 2024 - Approval of first in class, oral, Factor D inhibitor based on results from pivotal ALPHA Phase ...
Posted by Michael Wonder on 30 Mar 2024
FDA Approves Medexus's supplemental biologics license application for Ixinity to treat haemophilia B in paediatric patients
26 March 2024 - Expanded indication includes patients under 12 years of age, based on Phase 3/4 data demonstrating safety and ...
Posted by Michael Wonder on 28 Mar 2024
Akebia receives FDA approval of Vafseo (vadadustat) tablets for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis
27 March 2024 - Once daily oral HIF-PH inhibitor activates physiologic response to manage anaemia. ...
Posted by Michael Wonder on 26 Mar 2024
FDA approves Merck’s Winrevair (sotatercept-csrk), a first in class treatment for adults with pulmonary arterial hypertension (WHO Group 1)
26 March 2024 - Winrevair on top of background therapy significantly improved exercise capacity and multiple important secondary outcome measures ...
Posted by Michael Wonder on 25 Mar 2024
Regeneron provides update on biologics license application for odronextamab
25 March 2024 - Regeneron Pharmaceuticals today announced that the US FDA has issued complete response letters for the biologics license ...
Posted by Michael Wonder on 25 Mar 2024
Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder
25 March 2024 - Unprecedented relapse risk reduction observed in CHAMPION-NMOSD trial underscores how Ultomiris may redefine patient journey for ...
Posted by Michael Wonder on 25 Mar 2024
US FDA approves Opsynvi (macitentan and tadalafil) as the first and only once daily single tablet combination therapy for patients with pulmonary arterial hypertension
22 March 2024 - Approval is based on the results from the pivotal Phase 3 A DUE study, which met ...
Posted by Michael Wonder on 25 Mar 2024
US FDA approves broad new labels for Esperion’s Nexletol and Nexlizet to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use
22 March 2024 - Esperion today announced that the US FDA has approved broad new label expansions for Nexletol (bempedoic acid) ...
Posted by Michael Wonder on 23 Mar 2024
FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
22 March 2024 - Today, the FDA approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen) for adult patients with FRα positive, platinum-resistant epithelial ...
Posted by Michael Wonder on 21 Mar 2024
FDA approves non-steroidal treatment for Duchenne muscular dystrophy
21 March 2024 - Today, the US FDA approved Duvyzat (givinostat) oral medication for the treatment of Duchenne muscular dystrophy in ...