Blog
RSS FeedPosted by Michael Wonder on 22 Jan 2026
Thousands living with lupus offered hope from twice yearly infusion
22 January 2026 - NICE approves breakthrough combination treatment that restores normal kidney function in almost half of patients with lupus ...
Posted by Michael Wonder on 22 Jan 2026
IntraBio receives European Commission approval of Aqneursa for the treatment of Niemann-Pick type C disease
21 January 2026 - IntraBio today announced that the European Commission granted marketing authorisation to Aqneursa (levacetylleucine) for the treatment ...
Posted by Michael Wonder on 21 Jan 2026
Dawnzera (donidalorsen) granted European Union marketing authorisation for the prevention of hereditary angioedema
21 January 2026 - Otsuka announces that the European Commission has granted marketing authorization for Dawnzera (donidalorsen) for the routine ...
Posted by Michael Wonder on 19 Jan 2026
Sobi receives European Commission approval for Aspaveli (pegcetacoplan) for the treatment of C3G and primary IC-MPGN
16 January 2026 - Sobi today announced that the European Commission has approved Aspaveli (pegcetacoplan) for the treatment of adult ...
Posted by Michael Wonder on 19 Jan 2026
Eylea 8 mg approved in the EU for third retinal indication
16 January 2026 - The European Commission has granted marketing authorisation in the EU for Eylea™ 8 mg (aflibercept 8 mg, ...
Posted by Michael Wonder on 19 Jan 2026
SMC - January 2026 decisions
19 January 2026 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 19 Jan 2026
Organon announces US FDA approval of supplemental new drug application extending duration of use of Nexplanon (etonogestrel implant) 68 mg radiopaque
16 January 2026 - Organon announced today that the US FDA has approved a supplemental new drug application for Nexplanon (etonogestrel ...
Posted by Michael Wonder on 18 Jan 2026
Darzalex clears HIRA hurdle for AL amyloidosis reimbursement in Korea
16 January 2026 - The treatment barriers will likely be significantly lowered for patients with rare diseases in Korea, such ...
Posted by Michael Wonder on 17 Jan 2026
Fondazione Telethon receives european marketing authorisation for Waskyra (etuvetidigene autotemcel), a gene therapy for the treatment of Wiskott-Aldrich syndrome
16 January 2026 - The European Commission’s decision follows the positive opinion issued by the EMA’s CHMP in November 2025. ...
Posted by Michael Wonder on 16 Jan 2026
Santhera receives Swissmedic approval of Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy
15 January 2026 - Commercial launch in Switzerland anticipated in H2, 2026. ...
Posted by Michael Wonder on 14 Jan 2026
TGA approves registration of lenacapavir for pre-exposure prophylaxis for HIV (Yeytuo)
9 January 2026 - On 17 December 2025, the TGA made the decision to approve the registration of lenacapavir (Yeytuo). ...
Posted by Michael Wonder on 14 Jan 2026
Sandoz confirms European Commission approval of Ondibta (insulin glargine), strengthening overall biosimilars leadership and position in diabetes
14 January 2026 - Expected launch by early 2027; potential to expand access to insulin treatment option for tens of millions ...
Posted by Michael Wonder on 14 Jan 2026
Bimzelz (bimekizumab injection) approved in Canada for treatment of moderate to severe hidradenitis suppurativa
13 January 2026 - The approval is based on clinically significant results from UCB's two pivotal Phase 3 trials demonstrating ...
Posted by Michael Wonder on 13 Jan 2026
Health Canada approves Rybelsus (semaglutide tablets) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes
12 January 2026 - The indication expansion is based on positive outcomes observed in the cardiovascular outcomes (SOUL) trial data, ...
Posted 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 ...