13/02/2025: Clinical data published

The clinical data refer Gohibic, a treatment for adult patients with SARS-CoV-2 induced acute respiratory distress syndrome (ARDS) who receive systemic corticosteroids and invasive mechanical ventilation. More information on Gohibic is available on EMA's corporate website.

12/02/2025: Clinical data published

The clinical data refer to Iqirvo, a treatment for primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA. It is also indicated as a monotherapy in patients unable to tolerate UDCA. More information on Iqirvo is available on EMA's corporate website.

07/02/2025: Clinical data published

The clinical data refer to Alhemo, a medicine indicated for routine prophylaxis of bleeding. It is indicated in patients with haemophilia A and B that have reached the age of 12. More information on Alhemo is available on EMA’s corporate website.

06/02/2025: Clinical data published

The clinical data refer to Siiltibcy, a diagnostic aid to help detect Mycobacterium tuberculosis infection, including disease, in adults and children aged 28 days or older. More information on Siiltibcy is available on EMA’s corporate website.

06/02/2025: Clinical data published

The clinical data refer to the extension of indication for Ronapreve, a COVID-19 treatment. They support the inclusion of children aged 2 years and older who weigh at least 10 kg and do not require supplemental oxygen. More information on Ronapreve is availabe on EMA's corporate website.

06/02/2025: Clinical data published

The clinical data refer to a study evaluating the safety and effectiveness of Nuvaxovid, a COVID-19 vaccine. The study included adults aged between 18 and 84 in the United Kingdom. More information on Nuvaxovid is available on EMA’s corporate website.

30/01/2025: Clinical data published

The clinical data refer to Vyloy, a medicine indicated to treat a rare form of cancer in adults - locally advanced unresectable or metastatic adenocarcinoma. More information on Vyloy is available on EMA's corporate website.

21/01/2025: Clinical data published

The clinical data refer to Kayfanda, a medicine indicated for the cholestatic pruritus in alagille syndrome (ALGS) in patients aged 6 months or older. More information on Kayfanda is available on EMA's corporate website.

17/01/2025: Clinical data published

The clinical data refer to Bimervax, a vaccine indicated for the prevention of COVID-19 caused by SARS-CoV-2. More information about Bimervax is available on EMA's corporate website. 

16/01/2025: Clinical data published

The clinical data on Imvanex refer to an extension of indication including treatment of adolescents aged between 12 and 17 based on interim results from a study. This study is meant to inform public health strategies on the use of MVA-BN vaccine for mpox. More information on Imvanex is available on EMA’s corporate website.

16/01/2025: Clinical data published

The clinical data on Nuvaxovid refer to a final report from a safety study on immunogenicity. This relates to adults and adolescents aged between 12 and 18. More information on Nuvaxovid is available on EMA’s corporate website.

09/01/2025: Clinical data published

The clinical data refer to Bimervax, a vaccine indicated for the prevention of COVID-19 caused by SARS-CoV-2. More information about Bimervax is available on the EMA's corporate website.

09/01/2025: Clinical data published

The clinical data refer to Hympavzi, a medicine indicated for routine prophylaxis of bleeding episodes in patients aged 12 years and older, with haemophilia A or haemophilia B. More information about Hympavzi is available on the EMA's corporate website.

16/12/2024: Clinical data published

The clinical data refer to Elahere a medicine indicated for the treatment of ovarian, fallopian tube, or primary peritoneal cancer and designated as an orphan medicine. More information about Elahere is available on the EMA's corporate website.

29/11/2024: Clinical data published

The clinical data refer to Anzupgo a medicine indicated for the treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable or inappropriate. More information on Anzupgo is available on the EMA's corporate website.

29/11/2024: Clinical data published

The clinical data on Nuvaxovid refer to a final report from a study evaluating the safety and effectiveness of SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M adjuvant in South African adults living without HIV; and its safety and immunogenicity in people living with HIV. More information on Nuvaxovid is available on EMA’s corporate website.

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.