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European Commission (EC)

Pre-filled asthma pen approved for self-administration in EU

13 January 2023 | By Catherine Eckford (European Pharmaceutical Review)

Tezspire is the first biologic approved in Europe for severe asthma with no phenotype or biomarker limitation, says AstraZeneca EVP.

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EC approves influenza antiviral for children over one years old

12 January 2023 | By Catherine Eckford (European Pharmaceutical Review)

Xofluza® offers the first novel mechanism of action for an influenza antiviral to be approved by the European Commission in almost 20 years.

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Lynparza combination approved in EU for advanced prostate cancer

21 December 2022 | By Catherine Eckford (European Pharmaceutical Review)

Patients in the EU with an advanced prostate cancer will benefit from a newly approved Lynparza-based treatment combination for the first time.

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World’s first approval of an allogeneic T-cell immunotherapy

20 December 2022 | By Catherine Eckford (European Pharmaceutical Review)

Ebvallo™ is the first authorised allogeneic T-cell immunotherapy and has been approved for EU patients with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease.

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CHMP adopts positive opinion for haemophilia B gene therapy

16 December 2022 | By Catherine Eckford (European Pharmaceutical Review)

Gene therapy etranacogene dezaparvovec has been granted a positive opinion by the CHMP as a haemophilia B treatment for adults in Europe.

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European Commission approves first medicine for prurigo nodularis

15 December 2022 | By Catherine Eckford (European Pharmaceutical Review)

Dupixent®, the first and only targeted medicine for prurigo nodularis has been approved by the EC for adults with a moderate-to-severe form of the condition.

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European Commission approves Pluvicto^® for prostate cancer

13 December 2022 | By Catherine Eckford (European Pharmaceutical Review)

The European Commission has approved Pluvicto® as the first targeted radioligand therapy for advanced prostate cancer, based on significant results from the Phase III VISION trial.

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Comirnaty^® authorised for patients six months to four years

7 December 2022 | By Catherine Eckford (European Pharmaceutical Review)

Comirnaty® has been authorised by the MHRA as a vaccine to protect against Covid-19 for individuals from six months to four years old.

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First paediatric EC approval of HIV drug

30 November 2022 | By Catherine Eckford (European Pharmaceutical Review)

The European Commission has granted the first paediatric marketing authorisation for Gilead's low-dose Biktarvy® HIV tablet.

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Framework to enable re-use of patient clinical data

28 November 2022 | By Catherine Eckford (European Pharmaceutical Review)

A patient-centric legal framework intends to return clinical trial data to study participants, ready for re-use in further research or healthcare practice.

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EC approves Libtayo^® for metastatic cervical cancer

24 November 2022 | By Catherine Eckford (European Pharmaceutical Review)

The European Commission has approved Libtayo® for cervical cancer and disease progression while on or after platinum-based chemotherapy, due to positive Phase III trial results.

$livtencityTM - First oral treatment approved for post-transplant refractory cytomegalovirus$

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First oral treatment approved for post-transplant refractory cytomegalovirus

11 November 2022 | By Catherine Eckford (European Pharmaceutical Review)

The EC has authorised the first UL97 protein kinase inhibitor for adults with post-transplant refractory cytomegalovirus infection.

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EMA initiates rolling review of Valneva’s COVID-19 vaccine (VLA2001)

3 December 2021 | By Anna Begley (European Pharmaceutical Review)

The European Medicines Agency (EMA)'s human medicines agency (CHMP) begins a rolling review of Valneva's COVID-19 vaccine VLA2001 following positive preliminary results.

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CHMP issue positive opinion on Comirnaty^® for five to 11 year olds

1 December 2021 | By Anna Begley (European Pharmaceutical Review)

The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.

Woman sitting in wheelchair in hospital room

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European Commission grants marketing authorisation for Vumerity^®

17 November 2021 | By Anna Begley (European Pharmaceutical Review)

The European Commission (EC) has granted marketing authorisation for Vumerity® to treat adults with relapsing-remitting multiple sclerosis.

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European Commission (EC)