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RSS FeedPosted 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 01 Jun 2023
Rocket Pharmaceuticals receives EMA Priority Medicines (PRIME) designation for RP-A501 gene therapy for Danon disease
31 May 2023 - Rocket Pharmaceuticals today announced that the EMA has granted Priority Medicines (PRIME) designation to RP-A501, the ...
Posted by Michael Wonder on 30 May 2023
Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants
30 May 2023 - International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and ...
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 29 May 2023
How China could choke EU supply of medicines
24 May 2023 - Europe relies on China for the production of certain key drugs such as antibiotics. ...
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 26 May 2023
Janssen seeks European Commission approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of patients with relapsed and refractory multiple myeloma
25 May 2023 - Application to the EMA is supported by data from the Phase 3 CARTITUDE-4 study, which evaluated the ...