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RSS FeedPosted by Michael Wonder on 26 Apr 2024
Vertex announces European Commission approval for Kalydeco to treat infants with cystic fibrosis ages 1 month and older
26 April 2024 - Kalydeco is the first and only medicine approved in the EU in this age group to ...
Posted by Michael Wonder on 26 Apr 2024
Recommendations made by the PBAC (March 2024)
26 April 2024 - Recommendations made by the PBAC in March 2024 relating to the listing of medicines on the PBS ...
Posted by Michael Wonder on 26 Apr 2024
FDA grants Medivir´s MIV-711 rare paediatric disease designation and orphan drug designation for the treatment of Legg-Calvé-Perthes Disease
25 April 2024 - Medivir announced today that its selective cathepsin K inhibitor, MIV-711, has been granted rare paediatric disease designation ...
Posted by Michael Wonder on 26 Apr 2024
Melphalan flufenamide hydrochloride in combination with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma
25 April 2024 - NICE is unable to make a recommendation on the use of melphalan flufenamide hydrochloride (Pepaxti) in combination ...
Posted by Michael Wonder on 25 Apr 2024
Compass Therapeutics receives FDA fast track designation for the investigation of CTX-009 in combination with paclitaxel for the treatment of patients with metastatic or locally advanced biliary tract tumours that have been previously treated
25 April 2024 - Compass Therapeutics today announced that the US FDA has granted fast track designation to CTX-009, the Company’s ...
Posted by Michael Wonder on 25 Apr 2024
US FDA accepts for priority review GSK’s application for an expanded indication of Jemperli (dostarlimab) plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer
24 April 2024 - 23 August 2024 assigned as Prescription Drug User Fee Act action date for FDA decision. ...
Posted by Michael Wonder on 25 Apr 2024
Children and teenagers with an aggressive form of brain cancer set to benefit after NICE recommends new life-extending drug combination treatment
24 April 2024 - A new targeted drug combination treatment, described as a ‘step-change in care’ for children and young ...
Posted by Michael Wonder on 25 Apr 2024
Velsipity receives Health Canada approval for adults with moderately to severely active ulcerative colitis
24 April 2024 - Velsipity is a once daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P ...
Posted by Michael Wonder on 25 Apr 2024
Deverra Therapeutics granted FDA fast track designation for DVX101 (dilanubicel) for the treatment of acute myeloid leukaemia
24 April 2024 - Deverra Therapeutics today announced that the US FDA granted fast track designation to dilanubicel, the Company's ...
Posted by Michael Wonder on 25 Apr 2024
Bashing accelerated approval isn’t supported by the data
24 April 2024 - The FDA’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and ...
Posted by Michael Wonder on 25 Apr 2024
Travere Therapeutics and CSL Vifor announce European Commission approves Filspari (sparsentan) for the treatment of IgA nephropathy
24 April 2024 - Conditional marketing authorisation is based on statistically significant and clinically meaningful results from the Phase 3 ...
Posted by Michael Wonder on 25 Apr 2024
FDA approves new treatment for uncomplicated urinary tract infections
24 April 2024 - Today, the US FDA approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary ...
Posted by Michael Wonder on 24 Apr 2024
Pembrolizumab in combination with gemcitabine and cisplatin for the first-line treatment of patients with advanced biliary tract cancer
24 April 2024 - NICE is unable to make a recommendation on the use of pembrolizumab (Keytruda) in combination with cisplatin ...
Posted by Michael Wonder on 24 Apr 2024
Health Canada authorizes Tecentriq SC (atezolizumab solution for subcutaneous injection), the first cancer immunotherapy subcutaneous injection, for multiple cancer types
23 April 2024 - Roche Canada will be working closely with the pan-Canadian Pharmaceutical Alliance, as well as federal, provincial, ...
Posted by Michael Wonder on 24 Apr 2024
Averoa submits marketing authorisation application to the European Medicines Agency seeking approval of AVA1014 for treating complications associated with chronic kidney disease
23 April 2024 - Averoa announces the submission of a marketing authorisation application to the EMA for Ferric Citrate Coordination ...