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RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 17 Aug 2023
AbbVie announces European Commission approval of Aquipta (atogepant) for the preventive treatment of migraine in adults
17 August 2023 - Approval is based on two pivotal Phase 3 studies that demonstrated statistically significant reduction in mean ...
Posted by Michael Wonder on 01 Aug 2023
Marinus Pharmaceuticals announces European Commission approval of Ztalmy (ganaxolone) for the adjunctive treatment of epileptic seizures associated with CDKL5 deficiency disorder
31 July 2023 - Ztalmy is the first treatment approved by the European Commission for seizures associated with CDKL5 deficiency ...
Posted by Michael Wonder on 29 Jul 2023
European Commission approves Gilead’s Trodelvy for pre-treated HR positive, HER2 negative metastatic breast cancer
27 July 2023 - Approval based on clinically meaningful overall survival benefit demonstrated in the TROPiCS-02 study in pre-treated HR+/HER2- (IHC ...
Posted by Michael Wonder on 28 Jul 2023
Janssen submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Edurant
28 July 2023 - Parallel application also submitted to European Medicines Agency. ...
Posted by Michael Wonder on 27 Jul 2023
Soliris approved in the EU for children and adolescents with refractory generalised myasthenia gravis
27 July 2023 - First and only targeted therapy approved for paediatric patients with generalised myasthenia gravis in the EU ...
Posted by Michael Wonder on 26 Jul 2023
Jardiance (empagliflozin) approved in the EU for the treatment of adults with chronic kidney disease
25 July 2023 - Jardiance (empagliflozin) is the first SGLT-2 inhibitor to demonstrate a statistically significant reduction in all cause hospitalisations ...
Posted by Michael Wonder on 24 Jul 2023
ViiV Healthcare’s cabotegravir for HIV prevention receives positive CHMP opinion from European Medicines Agency
24 July 2023 - Positive opinion is based on results from the HPTN 083 and 084 Phase IIb/III studies in which ...