Blog
RSS FeedPosted by Michael Wonder on 15 Oct 2025
Corcept submits marketing authorisation application to EMA for relacorilant as a treatment for patients with platinum-resistant ovarian cancer
14 October 2025 - Corcept Therapeutics has submitted a marketing authorisation application to the EMA for relacorilant to treat patients ...
Posted by Michael Wonder on 09 Oct 2025
Ascendis submits marketing authorisation application to the EMA for TransCon CNP for treatment of children with achondroplasia
8 October 2025 - Ascendis Pharma today announced it has submitted a marketing authorisation application to the EMA for TransCon CNP ...
Posted by Michael Wonder on 07 Oct 2025
European marketing application for AVT23, a proposed biosimilar to Xolair (omalizumab), accepted by the EMA
6 October 2025 - Advanz Pharma today announced that the EMA has accepted a marketing authorisation application for AVT23, a proposed ...
Posted by Michael Wonder on 12 Sep 2025
Johnson & Johnson seeks first EMA approval for icotrokinra aiming to transform the plaque psoriasis treatment paradigm
11 September 2025 - Johnson & Johnson today announced the submission of an application to the EMA seeking the first approval ...
Posted by Michael Wonder on 11 Sep 2025
Enhertu type II variation application validated in the EU for previously treated patients with HER2 positive metastatic solid tumours
11 September 2025 - Submission based on three Phase 2 trials where Daiichi Sankyo and AstraZeneca’s Enhertu showed clinically meaningful ...
Posted by Michael Wonder on 06 Sep 2025
Accrufer assigned priority review in the US by FDA in children with iron deficiency anaemia
4 September 2025 - Pending successful review, approval in the US is anticipated in 2026. ...
Posted by Michael Wonder on 03 Sep 2025
Menarini Group's obicetrapib and obicetrapib/ezetimibe marketing authorisation applications accepted for review by the EMA for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia
2 September 2025 - Menarini today announced that EMA has validated the marketing authorisation application for obicetrapib, a selective cholesteryl ...
Posted by Michael Wonder on 26 Aug 2025
European Commission authorises twice yearly Yeytuo (lenacapavir) for HIV prevention
26 August 2025 - Accelerated EC decision comes after US FDA approval in June. ...
Posted by Michael Wonder on 21 Aug 2025
Rhythm Pharmaceuticals announces FDA acceptance of sNDA for setmelanotide in acquired hypothalamic obesity
20 August 2025 - US FDA accepts sNDA for filing with priority review; sets PDUFA goal date of 20 December 2025. ...
Posted by Michael Wonder on 19 Aug 2025
NewAmsterdam announces acceptance of marketing authorisation applications for review by EMA for obicetrapib
18 August 2025 - NewAmsterdam Pharma today announced that the EMA has validated the marketing authorisation application for obicetrapib 10 mg ...
Posted by Michael Wonder on 18 Aug 2025
Marketing authorisation application for CT001 has been submitted to the EMA for acute pain management in children
14 August 2025 - The marketing authorisation application for CT001 is submitted to the EMA for acute pain management in ...
Posted by Michael Wonder on 29 Jul 2025
Zevra Therapeutics submits marketing authorisation application to EMA to review arimoclomol for the treatment of Niemann-Pick disease type C
28 July 2025 - Zevra Therapeutics announced the company submitted a marketing authorisation application to the EMA for the evaluation of ...
Posted by Michael Wonder on 24 Jul 2025
Leriglitazone marketing authorisation application submitted for treatment of cerebral adrenoleukodystrophy has been validated by EMA
23 July 2025 - Minoryx Therapeutics and Neuraxpharm today announce that the marketing authorisation application for Minoryx’s lead candidate leriglitazone (Nezglyzal) ...
Posted by Michael Wonder on 21 Jul 2025
Bristol Myers Squibb’s supplemental new drug application for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis accepted for review across four regions globally
21 July 2025 - Bristol Myers Squibb today announced that the US FDA has accepted for review the supplemental new ...
Posted by Michael Wonder on 13 Jul 2025
Bayer files for EU approval of gadoquatrane
10 July 2025 - Submission of marketing authorization application to the EMA seeking approval for investigational low dose gadoquatrane for contrast-enhanced ...