Bayer files for approval of finerenone in heart failure in the EU

3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...

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Innovent receives second fast track designation from the US FDA for IBI363 (PD-1/IL-2α-bias bipspecific antibody fusion protein) in squamous non-small cell lung cancer

17 February 2025 - Innovent Biologics announced that its first in class PD-1/IL-2α-bias bi-specific antibody fusion protein, IBI363, has received its ...

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Innate Pharma announces US FDA granted breakthrough therapy designation to lacutamab for relapsed or refractory Sézary syndrome

17 February 2025 - Designation is based on TELLOMAK Phase 2 results demonstrating efficacy and a favourable safety profile in patients ...

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Unravelling the association between uncertainties in model-based economic analysis and funding recommendations of medicines in Australia

14 February 2025 - Health technology assessment is used extensively by the PBAC to inform medicine funding recommendations in Australia.  ...

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Out of pocket getting out of hand - reducing the financial toxicity of rapidly approved drugs

15 February 2025 - In 2023, Teresa was diagnosed with amyotrophic lateral sclerosis. Several months later, her family started a GoFundMe ...

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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. ...

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Cost sharing for preferred branded drugs in Medicare Part D

14 February 2025 - Most individuals in the US are concerned about prescription drug affordability. ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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Efanesoctocog alfa approved to prevent and treat bleeding in children and adults with severe or moderate haemophilia A

14 February 2025 - The MHRA has today approved efanesoctocog alfa (Altuvoct) to be used to treat and prevent bleeding in ...

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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 ...

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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. ...

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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 ...

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