Blog
RSS FeedPosted 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 03 Apr 2024
Dostarlimab in combination with platinum-based chemotherapy for the treatment of patients with advanced or recurrent, high microsatellite instability or mismatch repair deficiency endometrial cancer
3 April 2024 - NICE has published final evidence-based recommendations on the use of dostarlimab (Jemperli) in combination with platinum-based ...
Posted by Michael Wonder on 03 Apr 2024
European Commission expands approval of Bristol Myers Squibb’s Reblozyl (luspatercept) to include first-line treatment of transfusion-dependent anaemia in adults with lower-risk myelodysplastic syndromes
2 April 2024 - Approval of Reblozyl is based on head-to-head, pivotal Phase 3 COMMANDS study, in which Reblozyl nearly doubled ...
Posted by Michael Wonder on 02 Apr 2024
Polatuzumab vedotin in untreated diffuse large B-cell lymphoma: one step forward, two steps back
2 April 2024 - Roche designed its trial for both approval and health technology assessments but the analyses planned for ...
Posted by Michael Wonder on 02 Apr 2024
Mirum Pharmaceuticals’ Livmarli (maralixibat oral solution) receives positive reimbursement recommendation by Canada’s CADTH for patients with cholestatic pruritus in Alagille syndrome
2 April 2024 - Positive HTA recommendation for reimbursement signifies an important milestone towards public funding to treat eligible patients 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 29 Mar 2024
Paladin Labs announces approval of Wakix (pitolisant hydrochloride tablets) for use in paediatric patients in Canada
28 March 2024 - Indication includes children ages 6 years and older and weighing at least 30 kg. ...
Posted by Michael Wonder on 28 Mar 2024
Abilify Maintena 960 mg (aripiprazole) approved in the EU as the first once every two months long-acting injectable for the maintenance treatment of schizophrenia
27 March 2024 - Otsuka Pharmaceutical announces that its subsidiary Otsuka Pharmaceutical Europe and Lundbeck announced that the European Commission ...
Posted by Michael Wonder on 28 Mar 2024
European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy as neo-adjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer at high risk of recurrence in adults
28 March 2024 - Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable non-small cell lung ...
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 27 Mar 2024
Truqap plus Faslodex approved in Japan for patients with advanced HR positive breast cancer
27 March 2024 - Approval based on CAPItello-291 results which showed Truqap plus Faslodex reduced the risk of disease progression ...
Posted by Michael Wonder on 27 Mar 2024
Beyfortus approved in Japan for the prevention of RSV disease in infants
27 March 2024 - First and only RSV preventive option for broad infant population authorised for use in Japan. ...
Posted by Michael Wonder on 27 Mar 2024
Norgine receives positive CHMP opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia
26 March 2024 - Norgine today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of ...