16/04/2025: Clinical data published

The clinical data refer to Welireg, a treatment indicated for adults with advanced renal cell carcinoma (RCC) and adults with von Hippel-Lindau (VHL) disease. More information on Welireg is available on EMA's corporate website.

11/04/2025: Clinical data published

The clinical data refer to Kavigale, a medicine indicated for the pre-exposure prophylaxis of COVID-19 in patients aged 12 and over, and weighing at least 40 kilograms. It is also indicated for patients immunocompromised due to a medical condition or receipt of immunosuppressive treatments. More information on Kavgale is available on EMA’s corporate website.

10/04/2025: Clinical data published

The clinical data refer to a final study report on Nuvaxovid, a COVID-19 vaccine. It evaluated the safety, efficacy and effectiveness of the vaccine in adolescents. More information on Nuvaxovid is available on EMA’s corporate website.

09/04/2025: Clinical data published

The clinical data refer to Izelvay, a medicine indicated for the treatment of adults with geographic atrophy secondary to age-related macular degeneration. More information on Izelvay is available on EMA's corporate website.

07/04/2025: Clinical data published

The clinical data refer to Augtyro, a medicine indicated as a monotherapy for the treatment of adult patients with a form of advanced non-small cell lung cancer. It is also indicated for patients aged 12 years and older, with advanced solid tumours. More information on Augtyro is available on EMA’s corporate website.

07/04/2025: Clinical data published

The clinical data on COVID-19 medicine Spikevax refer to a final study report on the safety and effectiveness of mRNA-1273 vaccine in children aged 6 months to 11 years. More information on Spikevax is available on EMA’s corporate website.

02/04/2025: Clinical data published

The clinical data refer to Kostaive, a medicine indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. More information on Kostaive is available on EMA’s corporate website.

20/03/2025: Clinical data published

The clinical data refer to a final study report on Nuvaxovid, a COVID-19 vaccine. It evaluated the safety and effectiveness of Omicron subvariant and bivalent SARS-CoV-2 recombinant spike protein nanoparticle (SARS-CoV-2 rS) vaccines in previously vaccinated adults. More information on Nuvaxovid is available on EMA’s corporate website.

20/03/2025: Clinical data published

The clinical data refer to Wainzua, a treatment indicated for hereditary transthyretin-mediated amyloidosis (ATTRv) in adult patients with damaged peripheral nerves. ATTRv is a genetic disease in which transthyretin, a protein, deposits in patients' organs and tissues. More information on Wainzua is available on EMA's corporate website.

18/03/2025: Clinical data published

The clinical data refer to Syfovre, a withdrawn product indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). More information on Syfovre is available on EMA's corporate website.

11/03/2025: Clinical data published

The clinical data refer to Beyonttra, a medicine indicated for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy. More information on Beyonttra is available on EMA's corporate website.

06/03/2025: Clinical data published

The clinical data refer to Xevudy, a COVID-19 treatment. It refer to several studies and the final report evaluating the safety and effectiveness of the treatment. More information on Xevudy is available on EMA’s corporate website.

20/02/2025: Clinical data published

The clinical data refer to Hetronifly, a treatment indicated, in combination with carboplatin and etoposide, for adults with extensive stage small cell lung cancer. More information on Hetronifly is available on EMA's corporate website.

19/02/2025: Clinical data published

The clinical data refer to the withdrawn product Kinharto, a medicine indicated for the treatment of adult patients with symptomatic chronic heart failure and a reduced ejection fraction. More information on Kinharto is available on EMA's corporate website.

13/02/2025: Clinical data published

The clinical data refer to 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.