European Commission approves Biocon Biologics’ ustekinumab biosimilar

18 February 2025 - Biocon announced today that the European Commission granted marketing authorisation in the European Union for Yesintek, ...

Read more →

Galderma’s Nemluvio (nemolizumab) granted marketing authorisation in the United Kingdom and Switzerland for moderate to severe atopic dermatitis and prurigo nodularis

18 February 2025 - These are the first approvals of nemolizumab from countries within the Access Consortium framework, with regulatory review ...

Read more →

Welireg (belzutifan) receives first European Commission approval for two indications

18 February 2025 - Welireg is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union ...

Read more →

Samsung Bioepis gains European Commission approval for denosumab biosimilar (Obodence, Xbryk)

16 February 2025 - Obodence and Xbryk approved by the European Commission for all indications referencing Prolia and Xgeva, respectively. ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

US FDA approves expanded label for Astellas' Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy

12 February 2025 - Izervay dosing approved beyond 12 months. ...

Read more →

FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma

12 February 2025 - On 11 February 2025, the FDA approved brentuximab vedotin (Adcetris, Seagen) in combination with lenalidomide and a ...

Read more →