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RSS FeedPosted by Michael Wonder on 26 Jun 2026
Tryngolza (olezarsen) approved by the FDA as the first and only treatment to reduce triglycerides and the risk of acute pancreatitis in patients with severe hypertriglyceridemia
24 June 2026 - Ionis Pharmaceuticals today announced that the US FDA has approved Tryngolza (olezarsen) as an adjunct to ...
Posted by Michael Wonder on 26 Jun 2026
FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer
24 June 2026 - Today, the FDA approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences) for two indications in adults with triple ...
Posted by Michael Wonder on 26 Jun 2026
European Commission approves Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) as first PD-1 inhibitor plus antibody-drug conjugate regimen for adults with cisplatin-ineligible resectable muscle-invasive bladder cancer
24 June 2026 - Approval based on results from the Phase 3 KEYNOTE-905 trial in which perioperative Keytruda plus Padcev ...
Posted by Michael Wonder on 25 Jun 2026
FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR positive, HER2 positive metastatic breast cancer
24 June 2026 - Today, the FDA approved palbociclib (Ibrance, Pfizer) in combination with trastuzumab, with or without pertuzumab, and ...
Posted by Michael Wonder on 24 Jun 2026
Cemdisiran regulatory submissions accepted for review by FDA and EMA for the treatment of generalised myasthenia gravis
22 June 2026 - Regeneron Pharmaceuticals today announced that both the US FDA and EMA have accepted the regulatory applications for ...
Posted by Michael Wonder on 24 Jun 2026
Teva submits NDA for ecopipam, a first in class investigational therapy for paediatric Tourette syndrome
18 June 2026 - Teva Pharmaceutical Industries today announced the submission of a new drug application to the US FDA for ...
Posted by Michael Wonder on 24 Jun 2026
Sanofi’s Cenrifki (tolebrutinib) approved in the EU as the first disability targeting medicine for secondary progressive multiple sclerosis without relapses
23 June 2026 - The European Commission has approved Cenrifki (tolebrutinib) for the treatment of secondary progressive multiple sclerosis without relapses ...
Posted by Michael Wonder on 23 Jun 2026
ViiV Healthcare advances paediatric HIV regulatory submissions with FDA priority review for Tivicay PD and EMA validation of marketing application for Tivicay
22 June 2026 - ViiV Healthcare today announced that the US FDA has accepted the supplemental new drug application to ...
Posted by Michael Wonder on 23 Jun 2026
Laboratoires Pierre Fabre receives European Commission approval for Braftovi (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin, and oxaliplatin) for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer
22 June 2026 - Laboratoires Pierre Fabre announced today that the European Commission has approved Braftovi (encorafenib) in combination with cetuximab ...
Posted by Michael Wonder on 23 Jun 2026
US WorldMeds receives full US FDA approval of Tecelra (afamitresgene autoleucel) with an expanded indication, extending the first approved engineered T-cell therapy for a solid tumour to children as young as 12
22 June 2026 - US WorldMeds announced that the US FDA has granted full approval of Tecelra (afamitresgene autoleucel) and ...
Posted by Michael Wonder on 23 Jun 2026
FDA grants rolling review of Palvella’s Qtorin rapamycin NDA for microcystic lymphatic malformations
22 June 2026 - Palvella Therapeutics announced today that FDA has granted rolling review for the Company’s new drug application for ...
Posted by Michael Wonder on 23 Jun 2026
AbbVie announces European Commission approval of Skyrizi (risankizumab) for the treatment of paediatric patients with moderate to severe plaque psoriasis
23 June 2026 - AbbVie today announced that the European Commission has approved Skyrizi (risankizumab) for the treatment of children and ...
Posted by Michael Wonder on 23 Jun 2026
Arrowhead Pharmaceuticals receives marketing authorisation in the European Union for Redemplo (plozasiran) to reduce triglycerides in adults with familial chylomicronaemia syndrome
22 June 2026 - Arrowhead Pharmaceuticals today announced that the European Commission has formally granted marketing authorization for Redemplo (plozasiran), ...
Posted by Michael Wonder on 23 Jun 2026
AbbVie announces European Commission approval of Maviret (glecaprevir/pibrentasvir) for people with acute hepatitis C virus infection
23 June 2026 - AbbVie today announced that the European Commission approved Maviret (glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral therapy for ...
Posted by Michael Wonder on 23 Jun 2026
European Commission approves Trodelvy as a first-line treatment for metastatic triple negative breast cancer patients not candidates for PD-(L)1 inhibitors
23 June 2026 - Gilead Sciences today announced that the European Commission has granted marketing authorization for Trodelvy (sacituzumab govitecan-hziy) ...