Blog
RSS FeedPosted by Michael Wonder on 26 Apr 2024
US FDA approves Pfizer’s Beqvez (fidanacogene elaparvovec-dzkt), a one-time gene therapy for adults with hemophilia B
26 April 2024 - Pfizer announced today that the US FDA has approved Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adults ...
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
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
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 23 Apr 2024
Astellas' Xtandi (enzalutamide) granted European Commission approval for use in additional recurrent early prostate cancer treatment setting
23 April 2024 - Approval is based on results from the positive Phase 3 EMBARK study which showed Xtandi alone ...
Posted by Michael Wonder on 23 Apr 2024
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
21 April 2024 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s ...
Posted by Michael Wonder on 23 Apr 2024
Voydeya approved in the EU as add-on treatment to ravulizumab or eculizumab for adults with the rare disease PNH who have residual haemolytic anaemia
23 April 2024 - ALPHA Phase 3 trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris ...
Posted by Michael Wonder on 23 Apr 2024
Abeona Therapeutics provides regulatory update on Pz-cel
22 April 2024 - Abeona Therapeutics today announced a regulatory update for prademagene zamikeracel (pz-cel). ...
Posted by Michael Wonder on 23 Apr 2024
Health Canada approves new indication for Merck’s Prevymis (letermovir) for prevention of cytomegalovirus disease in high risk adult kidney transplant recipients
19 April 2024 - Merck announced that Health Canada has approved a new indication for Prevymis (letermovir) for the prophylaxis ...
Posted by Michael Wonder on 23 Apr 2024
European Commission approves Pfizer’s Emblaveo for patients with multidrug-resistant infections and limited treatment options
22 April 2024 - Emblaveo was reviewed under EMA accelerated assessment procedure, used when a pharmaceutical product is of major ...
Posted by Michael Wonder on 22 Apr 2024
FDA approves nogapendekin alfa inbakicept-pmln for BCG unresponsive non-muscle invasive bladder cancer
22 April 2024 - Today, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience) with Bacillus Calmette-Guérin (BCG) for adult ...
Posted by Michael Wonder on 22 Apr 2024
Carvykti (ciltacabtagene autoleucel) is the first BCMA targeted treatment approved by the European Commission for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy
22 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with ciltacabtagene autoleucel ...
Posted by Michael Wonder on 22 Apr 2024
Sandoz confirms European Commission approval of Pyzchiva (ustekinumab), further strengthening immunology offering
22 April 2024 - EC approval based on robust development program confirming match to reference medicine in terms of safety, ...
Posted by Michael Wonder on 22 Apr 2024
UCB receives European Commission approval for Bimzelx (bimekizumab) as the first IL-17A and IL-17F biologic for moderate to severe hidradenitis suppurativa
22 April 2024 - Approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD ...