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RSS FeedPosted by Michael Wonder on 05 Sep 2023
SK Bioscience withdraws conditional marketing authorisation for COVID-19 vaccine in EU
4 September 2023 - SK Bioscience said it has voluntarily withdrawn its application for a conditional marketing authorisation license to ...
Posted by Michael Wonder on 31 Aug 2023
InflaRx’s marketing authorisation application for vilobelimab for treatment of critically ill COVID-19 patients under review by European Medicines Agency
30 August 2023 - Regulatory submission based on pivotal data from PANAMO Phase III trial. ...
Posted by Michael Wonder on 30 Aug 2023
EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
30 August 2023 - The EMA’s CHMP has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant. ...
Posted by Michael Wonder on 30 Aug 2023
Withdrawn accelerated approvals for cancer indications in the US: what is the marketing authorisation status in the EU?
30 August 2023 - As of April, 2023, 23 accelerated approvals for cancer indications granted by the US FDA since 1992 ...
Posted by Michael Wonder on 30 Aug 2023
European Commission approves Roche’s Evrysdi for babies under two months old with spinal muscular atrophy
29 August 2023 - Approval is based on interim data from ongoing RAINBOWFISH trial showing majority of Evrysdi-treated babies were able ...
Posted by Michael Wonder on 30 Aug 2023
European Commission approves Keytruda (pembrolizumab) plus trastuzumab and chemotherapy as first-line treatment for HER2 positive advanced gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)
29 August 2023 - Approval based on progression-free survival benefit demonstrated in Phase 3 KEYNOTE-811 trial. ...
Posted by Michael Wonder on 28 Aug 2023
AbbVie submits regulatory applications to FDA and EMA for risankizumab (Skyrizi) in ulcerative colitis
29 August 2023 - Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical ...
Posted by Michael Wonder on 25 Aug 2023
European Commission approves Pfizer’s Abrysvo to help protect infants through maternal immunisation and older adults from RSV
24 August 2023 - Abrysvo is the first and only RSV vaccine approved in the European Union for both older ...
Posted by Michael Wonder on 25 Aug 2023
European Medicines Agency accepts Novaliq’s marketing authorisation application for CyclASol (cyclosporin ophthalmic solution) 0.1% for the treatment of dry eye disease
24 August 2023 - Novaliq today announced that the EMA has accepted the marketing authorisation application for CyclASol (ciclosporin ophthalmic ...
Posted by Michael Wonder on 24 Aug 2023
Cancer treatment uncertainty: European nations struggle with drug shortages
21 August 2023 - Experts in Europe detail the challenge with current cancer drug shortages and how regulators are trying ...
Posted by Michael Wonder on 23 Aug 2023
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma
22 August 2023 - Approval based on results from the Phase 3 CheckMate-76K trial in patients with stage IIB or ...
Posted by Michael Wonder on 21 Aug 2023
European Commission approves reduced dosing frequency for Janssen’s bispecific antibody Tecvayli (teclistamab)
18 August 2023 - Teclistamab, the first BCMA-targeting bispecific antibody to receive approval in Europe, maintained deep and durable responses, with ...
Posted by Michael Wonder on 19 Aug 2023
EMA accepts Leo Pharma’s marketing authorisation application for delgocitinib cream in chronic hand eczema
18 August 2023 - Leo Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, ...
Posted by Michael Wonder on 17 Aug 2023
European Medicines Agency accepts Iveric Bio’s marketing authorisation application for avacincaptad pegol for geographic atrophy
18 August 2023 - Astellas Pharma today announced the EMA has accepted for regulatory review the marketing authorisation application for ...
Posted by Michael Wonder on 17 Aug 2023
Odronextamab receives EMA filing acceptance for treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
17 August 2023 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for odronextamab ...