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RSS FeedPosted by Michael Wonder on 16 Feb 2025
Bavarian Nordic receives US FDA approval of chikungunya vaccine for persons aged 12 and older
14 February 2025 - On track for commercial launch in the US in the first half of 2025. ...
Posted by Michael Wonder on 16 Feb 2025
Galderma’s Nemluvio (nemolizumab) approved in the European Union for moderate to severe atopic dermatitis and prurigo nodularis
14 February 2025 - This approval from the European Commission is based on robust results from the Phase 3 OLYMPIA and ...
Posted by Michael Wonder on 16 Feb 2025
European Commission approves Egetis’ Emcitate (tiratricol) as the first and only treatment for patients with MCT8 deficiency
13 February 2025 - Egetis Therapeutics today announced that the European Commission has approved Emcitate (tiratricol) for the treatment of ...
Posted by Michael Wonder on 16 Feb 2025
FDA approves Samsung Bioepis’ Ospomyv, Xbryk (denosumab-dssb), a biosimilar to Prolia and Xgeva
15 February 2025 - Samsung Bioepis’ first endocrinology biosimilar to be approved by the FDA – widening its therapeutic areas and ...
Posted by Michael Wonder on 15 Feb 2025
Penmenvy, GSK’s 5 in 1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY
15 February 2025 - Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect ...
Posted by Michael Wonder on 15 Feb 2025
European Commission approves CSL and Arcturus Therapeutics’ Kostaive, the first self-amplifying mRNA COVID-19 vaccine
14 February 2025 - Kostaive represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to ...
Posted by Michael Wonder on 14 Feb 2025
FDA approves first rapid-acting insulin biosimilar product for treatment of diabetes
14 February 2025 - Agency continues efforts to increase access to insulin treatment options. ...
Posted by Michael Wonder on 14 Feb 2025
FDA approves vimseltinib for symptomatic tenosynovial giant cell tumour
14 February 2025 - Today, the FDA approved vimseltinib (Romvimza, Deciphera Pharmaceuticals), a kinase inhibitor, for adult patients with symptomatic ...
Posted by Michael Wonder on 14 Feb 2025
European Commission approves CSL's Andembry (garadacimab) for the prevention of recurrent attacks of hereditary angioedema
13 February 2025 - Supported by the Phase 3 VANGUARD trial, this marks the third regulatory approval for Andembry, which was ...
Posted by Michael Wonder on 14 Feb 2025
LIB Therapeutics announces FDA acceptance of biologics license application for lerodalcibep to lower LDL-cholesterol across broad patient population
10 February 2025 - FDA has set a PDUFA target action date of 12 December 2025. ...
Posted by Michael Wonder on 14 Feb 2025
Novartis receives Health Canada approval for Fabhalta oral treatment for adult patients with paroxysmal nocturnal haemoglobinuria
13 February 2025 - Fabhalta is the first oral monotherapy for previously treated and treatment naïve adults with paroxysmal nocturnal haemoglobinuria. ...
Posted by Michael Wonder on 13 Feb 2025
FDA grants fast track designation to PleoPharma's investigational new drug PP-01 for the mitigation of cannabis withdrawal symptoms in patients with cannabis use disorder: a potential first in class treatment
13 February 2025 - Phase 3 preparations underway. ...
Posted by Michael Wonder on 13 Feb 2025
FDA approves Roche’s Evrysdi tablet as first and only tablet for spinal muscular atrophy
12 February 2025 - New tablet formulation may provide greater freedom and independence for people with spinal muscular atrophy thanks ...
Posted by Michael Wonder on 13 Feb 2025
US FDA approves expanded label for Astellas' Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy
12 February 2025 - Izervay dosing approved beyond 12 months. ...
Posted by Michael Wonder on 13 Feb 2025
NKGen Biotech receives US FDA fast track designation for troculeucel for the treatment of moderate Alzheimer’s disease
12 February 2025 - NKGen Biotech today announced that the US FDA has granted fast track designation for the investigation of ...