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RSS FeedPosted by Michael Wonder on 13 Jan 2026
Galderma announces the authorisation of Nemluvio (nemolizumab) for atopic dermatitis and prurigo nodularis in Canada
12 January 2026 - Nemluvio is now authorised for sale by Health Canada based on results from the Phase III ARCADIA ...
Posted by Michael Wonder on 12 Jan 2026
Sanofi’s Teizeild approved in the EU for patients with stage 2 type 1 diabetes
12 January 2026 - Approval based on the TN-10 Phase 2 study that demonstrated a significant delay of onset of ...
Posted by Michael Wonder on 12 Jan 2026
FDA approves first treatment for children with Menkes disease
12 January 2026 - The US FDA today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease ...
Posted by Michael Wonder on 12 Jan 2026
Atara Biotherapeutics provides regulatory and business update on Ebvallo (tabelecleucel)
12 January 2026 - Atara Biotherapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 09 Jan 2026
GSK’s Shingrix (recombinant zoster vaccine) pre-filled syringe presentation approved by the European Commission
7 January 2026 - New presentation will begin rolling out across EU countries in 2026. ...
Posted by Michael Wonder on 08 Jan 2026
FDA approves new 2 gram presentation of Fibryga, enhancing convenience and precision in treating acquired fibrinogen deficiency
7 January 2026 - Octapharma today announced that the US FDA has approved a new 2 g presentation of Fibryga, fibrinogen ...
Posted by Michael Wonder on 07 Jan 2026
Maviret receives Health Canada approval for the treatment of acute hepatitis C virus
6 January 2026 - Maviret received approval through Health Canada's priority review process, based on data from the Phase 3 M20-350 ...
Posted by Michael Wonder on 06 Jan 2026
NICE recommends new treatment option for highly active multiple sclerosis
2 January 2026 - Thousands of people living with a form of multiple sclerosis will benefit from greater treatment choice, following ...
Posted by Michael Wonder on 06 Jan 2026
Idorsia’s Jeraygo (aprocitentan) approved in Canada for the treatment of resistant hypertension
5 January 2026 - Idorsia announces that Health Canada has granted marketing authorisation for Jeraygo (aprocitentan) for the treatment of resistant ...
Posted by Michael Wonder on 06 Jan 2026
Arrowhead Pharmaceuticals announces Health Canada approval of Redemplo (plozasiran) to reduce triglycerides in adults with familial chylomicronaemia syndrome
5 January 2026 - The Health Canada approval is based on positive results from the Phase 3 PALISADE study where Redemplo ...
Posted by Michael Wonder on 05 Jan 2026
SMC - December 2025 decisions
8 December 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 01 Jan 2026
Corcept receives complete response letter for relacorilant as a treatment for patients with hypercortisolism
31 December 2025 - Corcept Therapeutics today announced that the US FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 31 Dec 2025
Vanda Pharmaceuticals announces FDA approval of Nereus (tradipitant) for the prevention of vomiting induced by motion: a historic scientific milestone in the prevention of motion sickness
30 December 2025 - Vanda Pharmaceuticals today announced that the US FDA has approved Nereus (tradipitant), an oral neurokinin-1 receptor antagonist, ...
Posted by Michael Wonder on 30 Dec 2025
Unicycive Therapeutics announces resubmission of new drug application for oxylanthanum carbonate
29 December 2025 - New PDUFA date expected in 1H 2026 within 30 days of NDA resubmission. ...
Posted by Michael Wonder on 29 Dec 2025
US FDA approves Agios’ Aqvesme (mitapivat) for the treatment of anaemia in adults with alfa or beta-thalassaemia
23 December 2025 - Aqvesme expected to be available in late January 2026, following Aqvesme REMS program implementation. ...