Blog
RSS FeedPosted by Michael Wonder on 15 Sep 2020
Apellis announces submission of pegcetacoplan marketing applications to FDA and EMA for patients with PNH
15 September 2020 - -- Apellis Pharmaceuticals today announced that the company has submitted a new drug application to the ...
Posted by Michael Wonder on 10 Sep 2020
EU review extended for BioMarin's gene therapy Valrox
10 September 2020 - European regulators have requested more data to review the marketing application for BioMarin's haemophilia A gene ...
Posted by Michael Wonder on 09 Sep 2020
Ascendis Pharma submits marketing authorisation application to the EMA for TransCon hGH for the treatment of paediatric growth hormone deficiency
8 September 2020 - Ascendis Pharma announced today the submission of a marketing authorisation application to the EMA seeking approval for ...
Posted by Michael Wonder on 02 Sep 2020
EMA receives application for marketing authorisation of Dexamethasone Taw for COVID-19
2 September 2020 - EMA has started evaluating an application for the authorisation of Dexamethasone Taw for treating hospitalised adult patients ...
Posted by Michael Wonder on 25 Aug 2020
AbbVie aubmits regulatory application to FDA for Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis
25 August 2020 - In a pivotal Phase 2/3 study, twice as many patients receiving Rinvoq achieved the primary endpoint of ...
Posted by Michael Wonder on 20 Aug 2020
EMA agrees to review UCB's bimekizumab
18 August 2020 - Information about marketing authorisation application to EMA not yet disclosed by UCB. ...
Posted by Michael Wonder on 18 Aug 2020
European Medicines Agency has accepted for review a marketing authorisation application for Voraxaze
17 August 2020 - BTG Specialty Pharmaceuticals, today announced the EMA has accepted for review a marketing authorisation application for ...
Posted by Michael Wonder on 17 Aug 2020
PTC announces the acceptance of the European marketing authorisation application for Evrysdi (risdiplam) for the treatment of spinal muscular atrophy
17 August 2020 - Marketing authorisation application based on data from multiple pivotal trials in infants, children and adult patients with ...
Posted by Michael Wonder on 13 Aug 2020
European Medicines Agency validates BioMarin's marketing authorisation application for vosoritide to treat children with achondroplasia
13 August 2020 - Potential first medicine to treat achondroplasia in EU. ...
Posted by Michael Wonder on 03 Aug 2020
SIGA announces marketing authorisation filing for oral tecovirimat with the European Medicines Agency for multiple indications
30 July 2020 - Broader indication to include smallpox, monkeypox, cowpox and vaccinia complications. ...
Posted by Michael Wonder on 24 Jul 2020
BioMarin submits marketing authorisation application to European Medicines Agency for vosoritide to treat children with achondroplasia
23 July 2020 - If approved, vosoritide would be the first medicine to treat Achondroplasia in EU. ...
Posted by Michael Wonder on 21 Jul 2020
Molecular Partners provides regulatory update of European and Japanese filings of abicipar pegol
20 July 2020 - Molecular Partners today announced that Allergan, an AbbVie company, has informed Molecular Partners of their intent ...
Posted by Michael Wonder on 17 Jul 2020
EMA validates Bristol Myers Squibb’s application for CAR T cell therapy lisocabtagene maraleucel
17 July 2020 - Application based on positive results from TRANSCEND NHL 001 study and additional TRANSCEND WORLD 001 study. ...
Posted by Michael Wonder on 17 Jul 2020
MC2 Therapeutics announces submission of marketing authorisation application in EU for Wynzora cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate))
16 July 2020 - MC2 Therapeutics today announced the submission of its marketing authorisation application in EU for Wynzora cream (50 ...
Posted by Michael Wonder on 02 Jul 2020
Rhythm Pharmaceuticals announces submission of marketing authorization application to the European Medicines Agency for setmelanotide in POMC and LEPR deficiency obesities
1 July 2020 - Company also announces positive data from eight supplemental patients, including four paediatric patients, enrolled in pivotal ...