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RSS FeedPosted by Michael Wonder on 08 Jun 2023
European Commission authorises GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults
7 June 2023 - The authorisation is based on Phase 3 efficacy data in older adults. ...
Posted by Michael Wonder on 07 Jun 2023
UCB receives new European Commission approvals for Bimzelx (bimekizumab) for the treatment of psoriatic arthritis and axial spondyloarthritis
7 June 2023 - Bimekizumab is the first and only IL-17A and IL-17F inhibitor approved in the European Union for active ...
Posted by Michael Wonder on 06 Jun 2023
Fennec Pharmaceuticals announces European Commission marketing authorisation for Pedmarqsi (sodium thiosulphate) to reduce the risk of hearing loss in paediatric oncology patients
6 June 2023 - Pedmarqsi is the first and only approved therapy in the European Union for reducing the risk of ...
Posted by Michael Wonder on 06 Jun 2023
Novartis receives European approval for Cosentyx as first and only IL-17A inhibitor for hidradenitis suppurativa
1 June 2023 - European approval is based on robust Phase 3 data showing Cosentyx provided rapid symptom relief from as ...
Posted by Michael Wonder on 05 Jun 2023
TG Therapeutics announces European Commission approval for Briumvi (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis in adults
1 June 2023 - TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the European Commission (EC) has granted approval of ...
Posted by Michael Wonder on 01 Jun 2023
Samsung Bioepis obtains European Commission approval for Soliris biosimilar
30 May 2023 - Samsung Bioepis said that the European Commission has granted marketing authorization for Epysqli, a biosimilar referencing ...
Posted by Michael Wonder on 30 May 2023
Novavax's Nuvaxovid receives positive CHMP opinion for full marketing authorisation for the prevention of COVID in the EU
26 May 2023 - Novavax today announced that Nuvaxovid (NVX-CoV2373) has been recommended for full marketing authorisation for use as ...
Posted by Michael Wonder on 29 May 2023
CHMP adopts positive opinion to extend the use of Veklury (remdesivir) to treat COVID-19 in people with severe renal impairment, including those on dialysis
26 May 2023 - If granted by the European Commission, Veklury will become the first and only authorised anti-viral treatment ...
Posted by Michael Wonder on 29 May 2023
Ipsen receives CHMP negative opinion, following re-examination of potential first FOP treatment in the EU
26 May 2023 - Regulatory processes are continuing in other countries including the US. ...
Posted by Michael Wonder on 29 May 2023
Once weekly Sogroya (somapacitan) receives CHMP positive opinion for expanded use in children and adolescents with growth hormone deficiency
26 May 2023 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion, recommending once weekly Sogroya ...
Posted by Michael Wonder on 29 May 2023
EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo
26 May 2023 - The EMA’s CHMP has recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing ...
Posted by Michael Wonder on 29 May 2023
Marinus Pharmaceuticals receives positive CHMP opinion for Ztalmy (ganaxolone) for the adjunctive treatment of seizures associated with CDKL5 deficiency disorder
26 May 2023 - The European Commission decision is expected within 67 days of the CHMP opinion. ...
Posted by Michael Wonder on 28 May 2023
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in patients with tumour cell PD-L1 expression ≥1%
26 May 2023 - Recommendation based on results from the Phase 3 CheckMate-816 trial, in which Opdivo with chemotherapy demonstrated improved ...
Posted by Michael Wonder on 27 May 2023
Highlights from the CHMP 22-25 May 2023 meeting
26 May 2023 - The EMA’s CHMP recommended two medicines for approval at its May 2023 meeting. ...
Posted by Michael Wonder on 10 May 2023
Ultomiris approved in the EU for adults with neuromyelitis optica spectrum disorder
10 May 2023 - Ultomiris transforms the treatment landscape for anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder patients, with potential to eliminate ...