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RSS FeedPosted 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 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 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 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 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 ...
Posted by Michael Wonder on 24 Jul 2023
Jazz Pharmaceuticals receives CHMP positive opinion for JZP458 (a recombinant Erwinia asparaginase or crisantaspase) for the treatment of acute lymphoblastic leukaemia and lymphoblastic lymphoma
21 July 2023 - Jazz Pharmaceuticals today announced that the EMA's CHMP adopted a positive opinion recommending the marketing authorisation of ...
Posted by Michael Wonder on 24 Jul 2023
Biocon Biologics announces positive CHMP opinion for Yesafili, biosimilar aflibercept
24 July 2023 - Biocon Biologics today announced that the EMA’s CHMP has issued a positive opinion recommending approval of ...
Posted by Michael Wonder on 24 Jul 2023
Sandoz receives positive CHMP opinion for multiple sclerosis biosimilar natalizumab
24 July 2023 - Positive CHMP opinion based on evidence from extensive analytical characterisation confirming similarity of biosimilar with reference biologic, ...
Posted by Michael Wonder on 24 Jul 2023
First RSV vaccine to protect infants up to 6 months of age and older adults
21 July 2023 - EMA has recommended granting a marketing authorisation in the European Union for Abrysvo, a vaccine to protect ...