Blog
RSS FeedPosted by Michael Wonder on 04 Sep 2020
PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids
4 September 2020 - A review by EMA’s safety committee has confirmed that 5 mg ulipristal acetate (Esmya and generic ...
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 01 Sep 2020
Imfinzi approved in the EU for the treatment of extensive-stage small cell lung cancer
1 September 2020 - Only PD-1/PD-L1 immunotherapy to demonstrate a significant survival benefit and improved response rate in combination with a ...
Posted by Michael Wonder on 27 Aug 2020
European Commission approves Blenrep (belantamab mafodotin) for the treatment of patients with relapsed and refractory multiple myeloma
26 August 2020 - Marketing authorisation follows the recent US approval of Blenrep. ...
Posted by Michael Wonder on 27 Aug 2020
The EU Commission grants conditional approval for Idefirix (imlifidase) in highly sensitised kidney transplant patients in the European Union
26 August 2020 - The conditional approval by the European Commission serves as a landmark milestone for Hansa Biopharma, as Idefirix ...
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 24 Aug 2020
EMA goes all-virtual for remainder of 2020
20 August 2020 - The EMA has announced that all its committee and working party meetings will be held virtually ...
Posted by Michael Wonder on 24 Aug 2020
European Commission approves Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat cystic fibrosis in people ages 12 years and older
21 August 2020 - For the first time, up to 10,000 people in Europe ages 12 years and older with one ...
Posted by Michael Wonder on 21 Aug 2020
Samsung Bioepis receives European Commission approval for Aynbintio (bevacizumab)
20 August 2020 - Aybintio is Samsung Bioepis’ fifth biosimilar to be approved by the European Commission. ...
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
EMA publishes agenda for 17-20 August CHMP meeting
18 August 2020 - The EMA has published a draft agenda for this week's CHMP meeting (written procedure). ...
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 17 Aug 2020
AstraZeneca seals deal with EC for coronavirus vaccine supply
17 August 2020 - AstraZeneca has finalised an agreement with the European Commission to supply up to 400 million doses ...
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. ...