Blog
RSS FeedPosted 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 28 Mar 2024
89bio receives EMA PRIME status for pegozafermin in the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis and compensated cirrhosis
27 March 2024 - PRIME status is supported by positive data from the Phase 2b ENLIVEN trial of pegozafermin. ...
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 ...
Posted by Michael Wonder on 27 Mar 2024
PHARMAC funds new treatments for breast and blood cancer
27 March 2024 - PHARMAC is funding two new cancer treatments, one for advanced breast cancer (ribociclib succinate) and one ...
Posted by Michael Wonder on 27 Mar 2024
Satralizumab for the prevention of relapse in patients with a neuromyelitis optica spectrum disorder
27 March 2024 - NICE is unable to make a recommendation on the use of satralizumab (Enspryng) for the prevention of ...
Posted by Michael Wonder on 27 Mar 2024
Syndax announces FDA priority review of NDA for revumenib for the treatment of relapsed/refractory KMT2Ar acute leukaemia
26 March 2024 - PDUFA action date set for 26 September 2024. ...
Posted by Michael Wonder on 27 Mar 2024
Daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone for the treatment of adults with newly diagnosed systemic light chain amyloidosis
27 March 2024 - NICE has published final evidence-based recommendations on the use of daratumumab (Darzalex) for the treatment of ...
Posted by Michael Wonder on 27 Mar 2024
Takeda announces approval of Adzynma intravenous injection 1500 (apadamtase alfa/cinaxadamtase alfa) in Japan for patients with congenital thrombotic thrombocytopenic purpura
26 March 2024 - Adzynma (apadamtase alfa/cinaxadamtase alfa) is the first and only recombinant ADAMTS13 enzyme replacement therapy for people with congenital ...
Posted by Michael Wonder on 27 Mar 2024
Ritlecitinib tosylate for the treatment of people 12 years and over with alopecia areata
27 March 2024 - NICE has published final evidence-based recommendations on the use of ritlecitinib tosylate (Litfulo) for the treatment ...
Posted by Michael Wonder on 27 Mar 2024
Patient advocates clash over wisdom of ‘approving drugs faster and faster’
26 March 2024 - Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated ...
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 26 Mar 2024
Astellas' Vyloy (zolbetuximab) approved in Japan for treatment of gastric cancer
26 March 2024 - MHLW approval makes Vyloy the first and only CLDN18.2-targeted therapy approved in the world. ...
Posted by Michael Wonder on 26 Mar 2024
Cost and value of cancer medicines in a single payer public health system in Ontario, Canada: a cross-sectional study
26 March 2024 - We describe temporal trends in expenditure on cancer medicines within the single-payer health system of Ontario, Canada, ...