Blog
RSS FeedPosted by Michael Wonder on 25 Jan 2022
Vyepti (eptinezumab) approved by the EU Commission for the preventive treatment of migraine in adults
24 January 2022 - Vyepti is the first intravenous treatment approved for migraine prevention in Europe. ...
Posted by Michael Wonder on 20 Jan 2022
ChemoCentryx announces EU approval of Tavneos (avacopan) for the treatment of ANCA associated vasculitis
19 January 2022 - ChemoCentryx today announced that Tavneos (avacopan) has been approved within the European Union in combination with a ...
Posted by Michael Wonder on 17 Jan 2022
Serb receives EU approval for Voraxaze (glucarpidase) as rescue therapy for high dose methotrexate toxicity
14 January 2022 - Serb and BTG Specialty Pharmaceuticals today announced that the European Commission has granted marketing authorisation for ...
Posted by Michael Wonder on 16 Jan 2022
Ascendis Pharma receives European Approval for TransCon hGH for paediatric growth hormone deficiency
13 January 2022 - TransCon hGH (approved by the European Commission as Lonapegsomatropin Ascendis Pharma) is a once-weekly prodrug of somatropin ...
Posted by Michael Wonder on 11 Jan 2022
European Commission approves Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat children with cystic fibrosis ages 6 to 11 years
11 January 2022 - More than 1,500 children now eligible to receive a treatment targeting the underlying cause of cystic ...
Posted by Michael Wonder on 11 Jan 2022
European Commission approves Lumykras (sotorasib) for patients with KRAS G12C mutated advanced non-small cell lung cancer
10 January 2022 - Approval based on pivotal CodeBreaK 100 data demonstrating durable responses and a favourable benefit-risk profile with Lumykras ...
Posted by Michael Wonder on 11 Jan 2022
SIGA Technologies receives approval from the European Medicines Agency for tecovirimat
10 January 2021 - Broader indication to include smallpox, monkeypox, cowpox and vaccinia complications. ...
Posted by Michael Wonder on 20 Dec 2021
EMA recommends Nuvaxovid for authorisation in the EU
20 December 2021 - EMA has recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid (also known as ...
Posted by Michael Wonder on 20 Dec 2021
EMA adopts a positive CHMP opinion for Pfizer’s and OPKO’s somatrogon, a long-acting treatment for paediatric growth hormone deficiency
17 December 2021 - If approved by the European Commission, somatrogon will offer children and adolescents living with growth hormone ...
Posted by Michael Wonder on 20 Dec 2021
Saphnelo recommended for approval in the EU by CHMP for the treatment of patients with systemic lupus erythematosus
20 December 2021 - Saphnelo is a first-in-class type I interferon receptor antibody shown to reduce overall disease activity in ...
Posted by Michael Wonder on 20 Dec 2021
CHMP issues positive opinion for Pfizer’s 20 valent pneumococcal conjugate vaccine for the prevention of vaccine type pneumococcal pneumonia in adults
17 December 2021 - Pfizer announced today that the CHMP of the EMA has issued a positive opinion to recommend the ...
Posted by Michael Wonder on 19 Dec 2021
Pfizer receives positive CHMP opinion for Lorviqua (lorlatinib) as first-line treatment for ALK positive advanced lung cancer
17 December 2021 - Recommendation based on results from the Phase 3 CROWN trial, which showed Lorviqua reduced the risk of ...
Posted by Michael Wonder on 18 Dec 2021
New treatment for sickle cell disease
17 December 2021 - EMA has recommended granting a marketing authorisation in the EU for Oxbryta (voxelotor) for the treatment of ...
Posted by Michael Wonder on 18 Dec 2021
Astellas and Seagen receive positive CHMP opinion for Padcev (enfortumab vedotin) in locally advanced or metastatic urothelial cancer
17 December 2021 - If approved, PADCEV would be the first medicine for patients in the EU who have received prior ...
Posted by Michael Wonder on 18 Dec 2021
Tepmetko (tepotinib) receives positive CHMP opinion for patients with advanced NSCLC with METex14 skipping alterations
17 December 2021 - Tepmetko is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe ...