19/11/2024: Clinical data published

The clinical data refer to Winrevair, a medicine indicated in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients, with moderate or marked limitations of physical activity, to improve exercise capacity. More information on Winrevair is available on the EMA's corporate website.

19/11/2024: Clinical data published

The clinical data refer to Piasky a medicine indicated as monotherapy for the treatment of adult and paediatric patients 12 years of age or older, with paroxysmal nocturnal haemoglobinuria (PNH). More information on Piasky is available on the EMA's corporate website.

13/11/2024: Clinical data published

The clinical data refer to Vaxzevria, a vaccine indicated for active immunisation to prevent COVID-19. More concretely, to the submission of a final report from a relevant study. More information on Vaxzevria is available on EMA’s corporate website.

07/11/2024: Clinical data published

The clinical data refer to Balversa as monotherapy. It is indicated for the treatment of adults with unresectable or metastatic urothelial carcinoma (UC) harbouring susceptible genetic alterations, who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor. More information on Balversa is available on EMA's corporate website.

24/10/2024 Join EMA's clinical data publication webinar 

EMA is inviting stakeholders interested in and / or intending to submit clinical data for publication to attend its webinar on the planned expansion of clinical data publication. The webinar will take place on 14 November 2024. EMA will broadcast it live. Find more details on EMA's corporate website.

24/10/2024: Clinical data published

The clinical data refer to Loqtorzi, a medicine indicated, in combination with cisplatin and gemcitabine, for the first line treatment of nasopharyngeal carcinoma and oesophageal squamous cell carcinoma in adults. More information on Loqtorzi is available on EMA's corporate website.

21/10/2024: Clinical data published

The clinical data refer to Beqvez (Durveqtix), a medicine indicated for the treatment of severe and moderately severe haemophilia B in adults. More information on Beqvez is available on EMA's corporate website.

15/10/2024: Clinical data published

The clinical data refer to Truqap, a medicine indicated for adults seeking treatment for specific types of metastatic breast cancer, following recurrence or progression or after an endocrine-based regimen. More information on Truqap is available on EMA's corporate website.

15/10/2024: Clinical data published

The clinical data refer to Tauvid, a medicine for diagnostic use only. It is indicated for adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD). As a radiopharmaceutical, it serves for positron emission tomography (PET) imaging of the brain. More information on Tauvid is available on EMA's corporate website. 

10/10/2024: Clinical data published

The clinical data on Comirnaty refer to the submission of the final and supplemental reports from study C4591031, substudy E. More information on Comirnaty is available on EMA's corporate website

07/10/2024: Clinical data published

The clinical data on Nuvaxovid refer to a final report from a study evaluating the safety and effectiveness of the JN.1 variant strain vaccines in previously vaccinated people. More information on Nuvaxovid is available on EMA’s corporate website.

07/10/2024: Clinical data published

The clinical data refer to Adzynma, a medicine indicated for treatment of ADAMTS13 deficiency in children and adult patients with congenital thrombotic thrombocytopenic purpura (cTTP).
More information on Adzynma is available on EMA's corporate website. 

03/10/2024: Clinical data published

The clinical data refer to Ixchiq, a medicine indcated for prevention of disease caused by the chikungunya (CHIKV) virus. More information on Ixchiq is available on the EMA's corporate website.

26/09/2024: Clinical data published

The clinical data refer to Ordspono, a medicine indicated as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy. It is also indicated for treatment of refractory diffuse large B cell lymphoma (r/r DLBCL) after two or more lines of systemic therapy. More information on Ordspono is available on EMA's corporate website.

19/09/2024: Clinical data published

The clinical data refer to Qalsody, a medicine indicated for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene. More information on Qalsody is available on EMA's corporate website.

17/09/2024: Further clinical data for COVID-19 medicine published

The clinical data on Nuvaxovid refer to a final report from a study evaluating the safety and immunogenicity of Omicron subvariant and bivalent SARS-CoV-2 rS vaccines in adults previously vaccinated with other COVID-19 vaccines. More information on Nuvaxovid is available on EMA’s corporate website.

12/09/2024: Clinical data published

The clinical data refer to Zegalogue, a medicine indicated for treatment of severe hypoglycaemia in adults, adolescents and children aged 6 years and over with diabetes mellitus. More information on Zegalogue is available on EMA's corporate website.

12/09/2024: Clinical data published

The clinical data refer to Altuvoct, a medicine indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency), in all age groups. More information on Altuvoct is available on EMA's corporate website.

12/09/2024: Clinical data published

The clinical data refer to Jeraygo, a medicine used to treat resistant hypertension in adults. More information on Jeraygo is available on EMA's corporate website.

05/09/2024: Clinical data published

The clinical data refer to mRESVIA, a medicine indicated for prevention of lower respiratory tract disease and acute respiratory disease caused by respiratory syncytial virus. It is indicated for adults 60 years and older. More information on mRESVIA is available on EMA's corporate website.

02/09/2024: Clinical data published

The clinical data refer to Nezglyal, a medicine for which the CHMP refused the granting of marketing authorisation. This medicine was intended for the treatment of cerebral adrenoleukodystrophy, a genetic condition that damages the membrane covering nerve cells in the brain and spinal cord. More information on Nezglyal is available on EMA's corporate website. 

28/08/2024: Clinical data published

The clinical data refer to Awiqli, a medicine indicated for treatment of diabetes mellitus in adults. More information on Awiqli is available on EMA's corporate website. 

21/08/2024: Clinical data published

The clinical data refer to Cejemly, a medicine indicated for the first line treatment of adults with metastatic non small cell lung cancer (NSCLC), under certain conditions. More information on Cejemly is available on EMA's corporate website.

14/08/2024: Clinical data published

The clinical data refer to a final report from a study evaluating the safety, reactogenicity and immunogenicity of Jcovden and influenza vaccines in healthy adults. More information on Jcovden is available on EMA's corporate website.

14/08/2024: Clinical data published

The clinical data refer to Fruzaqla. The active substance Fruquintinib (HMPL-013) is a small molecule antitumor quinazoline class tyrosine kinase inhibitor, highly selective and potent inhibitor of the vascular endothelial growth factor receptor (VEGFR). The underlying signaling pathway plays a key role in tumor angiogenesis and tumor growth. Thus, targeting of the VEGF signaling pathway is a well-accepted strategy for anticancer therapy. More information on Fruzaqla's is available on EMA's corporate website.

01/08/2024: Clinical data published

The clinical data refer to Obgemsa (vibegron), a medicine indicated for the treatment of adults with overactive bladder syndrome. More information on Obgemsa is available on EMA’s corporate website.

01/08/2024: Further clinical data for COVID-19 medicine published

The clinical data refer to a final report from a study evaluating the safety and immunogenicity of COVID-19 vaccine Nuvaxovid in previously vaccinated people. More information on Nuvaxovid is available on EMA’s corporate website.

01/08/2024: Clinical data published

The clinical data refer to Emblaveo (aztreonam/avibactam), a medicine indicated for the treatment of adults with complicated urinary tract infections and hospital-acquired pneumonia. More information on Emblaveo is available on EMA’s corporate website.

25/07/2024: Further clinical data for COVID-19 medicine published

The clinical data refer to a final report from a study evaluating the safety and immunogenicity of COVID-19 vaccine Vaxzevria in previously vaccinated and unvaccinated adults. More information on Vaxzevria is available on EMA’s corporate website.

25/07/2024: Clinical Data published

The clinical data refer to Fabhalta (iptacopan), a medicine used in adults with paroxysmal nocturnal haemoglobinuria (PNH) to treat haemolytic anaemia. More information on Fabhalta is available on EMA’s corporate website.

22/07/2024: Further clinical data for COVID-19 medicine published

The clinical data on the COVID-19 vaccine Jcovden refer to a final report from three studies conducted in people aged 18 or older with no new safety concerns. More information on Jcovden is available on EMA’s corporate website.

28/06/2024: Further clinical data for COVID-19 medicine published

The clinical data on COVID-19 vaccine Spikevax refer to final reports of two studies evaluating the safety and immunogenicity of its mRNA-1273 booster when administered in combination with other vaccines in adults. More information on Spikevax is available on EMA's corporate website.

28/06/2024: Clinical data published

The clinical data refer to Filspari (sparsentan), a medicine for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). More information on Filspari is available on EMA's corporate website.

26/06/2024: Clinical data published

The clinical data refer to Voydeya (danicopan), a medicine indicated as an add-on therapy to ravulizumab or eculizumab for the treatment of residual haemolytic anaemia in adult patients with paroxysmal nocturnal haemoglobinuria (PNH). More information on Voydeya is available on EMA's corporate website.

19/06/2024: Clinical data published

The clinical data refer to Incellipan, a monovalent inactivated influenza vaccine, which uses surface antigens from a potential pandemic H5N1 virus strain candidate. More information on Incellipan is available on EMA’s corporate website.

19/06/2024: Clinical data published

The clinical data refer to Celldemic, a monovalent inactivated influenza vaccine, which uses surface antigens from a potential pandemic H5N1 virus strain candidate. More information on Celldemic is available on EMA’s corporate website.

13/06/2024: Clinical data published

The clinical data refer to Ryzneuta (efbemalenograstim alfa), a medicine indicated for the treatment of neutropenia in adult patients receiving cytotoxic chemotherapy for malignant disease (with some exceptions). More information on Ryzneuta is available on EMA’s corporate website.

13/06/2024: Clinical data published

The clinical data refer to Exblifep (cefepime / enmetazobactam), a medicine indicated for the treatment in adults of infections such as complicated urinary tract infections and hospital-acquired pneumonia. More information on Exblifep is available on EMA’s corporate website.

13/06/2024: Clinical data published

The clinical data refer to Velsipity (etrasimod), a medicine indicated for the treatment of moderately to severely active ulcerative colitis in patients aged 16 years and older. More information on Velsipity is available on EMA’s corporate website.

06/06/2024: Clinical data published

The clinical data refer to Tizveni (tislelizumab), indicated in the treatment of adult patients with locally or metastatic non-small cell lung cancer (NSCLC). More information on Tizveni is available on EMA's corporate website.

06/06/2024: Clinical data published

The clinical data on COVID-19 vaccine Bimervax refer to a final report from a study evaluating the safety and immunogenicity of booster vaccination in adults previously vaccinated against COVID-19. More information on Bimervax is available on EMA's corporate website.

30/05/2024: Further clinical data for COVID-19 medicine published

The clinical data on COVID-19 vaccine Spikevax refer to a final report from a study evaluating the efficacy, safety and immunogenicity of its mRNA-1273 booster in adults. More information on Spikevax is available on EMA's corporate website.

30/05/2024: Clinical data published

The clinical data refer to Zynyz (retifanlimab), an orphan medicine used in adults to treat Merkel cell carcinoma (a type of skin cancer) that cannot be cured by surgery or radiation therapy. More information on Zynyz is available on EMA's corporate website.

30/05/2024: Clinical data published

The clinical data refer to Skyclarys (omaveloxolone), an orphan medicine indicated for the treatment of Friedreichs ataxia in patients aged 16 years and older. More information on Skyclarys is available on EMA's corporate website.

16/05/2024: Clinical data published

The clinical data refer to Casgevy (exagamglogene autotemcel), an orphan medicine used to treat blood disorders known as beta thalassaemia and sickle cell disease in patients aged 12 and older. More information on Casgevy is available on EMA's corporate website.