Blog
RSS FeedPosted by Michael Wonder on 19 Apr 2024
US FDA approves subcutaneous administration of Takeda’s Entyvio (vedolizumab) for maintenance therapy in moderately to severely active Crohn’s disease
19 April 2024 - Entyvio is now available in the US in both intravenous and subcutaneous administrations for maintenance treatment ...
Posted by Michael Wonder on 18 Apr 2024
Lumicell’s cutting-edge imaging platform receives historic FDA approval to illuminate residual breast cancer
18 April 2024 - Lumisight and Lumicell DVS previously received FDA fast track and breakthrough device designations, respectively. ...
Posted by Michael Wonder on 18 Apr 2024
FDA approves Genentech's Alecensa as first adjuvant treatment for people with ALK positive early stage lung cancer
18 April 2024 - Approval based on Phase 3 ALINA study showing Alecensa reduced the risk of disease recurrence or death ...
Posted by Michael Wonder on 18 Apr 2024
Alvotech and Teva announce US FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab)
16 April 2024 - Selarsdi is expected to be marketed in the US on or after 21 February 2025, following a ...
Posted by Michael Wonder on 11 Apr 2024
Fasenra approved for treatment of children aged 6 to 11 with severe asthma
11 April 2024 - AstraZeneca’s Fasenra (benralizumab) is now approved by the US FDA for add-on maintenance treatment for patients ...
Posted by Michael Wonder on 09 Apr 2024
ViiV Healthcare announces US FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV
8 April 2024 - Dovato is now the first and only oral, two drug, single-tablet regimen available for people aged 12 ...
Posted by Michael Wonder on 09 Apr 2024
Supernus provides regulatory update for SPN-830
8 April 2024 - Supernus Pharmaceuticals today announced a regulatory update for SPN-830. ...
Posted 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. ...