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RSS FeedPosted by Michael Wonder on 13 Jul 2024
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in giant cell arteritis
12 July 2024 - Submissions are supported by the Phase 3 SELECT-GCA study demonstrating upadacitinib 15 mg with a 26 week ...
Posted by Michael Wonder on 10 Jul 2024
Aplidin will be re-evaluated by the EMA. The European Commission revokes the decision that initially denied PharmaMar's marketing authorisation for multiple myeloma due to a conflict of interest.
8 July 2024 - The European Commission has acknowledged that an expert from the Scientific Advisory Group, who was developing a ...
Posted by Michael Wonder on 10 Jul 2024
Mirum Pharmaceuticals’ Livmarli approved in the European Union for patients with progressive familial intrahepatic cholestasis
8 July 2024 - Mirum Pharmaceuticals today announced that the European Commission has granted marketing authorization for Livmarli (maralixibat) oral solution ...
Posted by Michael Wonder on 06 Jul 2024
Submission of Nidlegy marketing authorisation application validated by EMA
4 July 2024 - The assessment period of the dossier by the authorities has started on 20 June. ...
Posted by Michael Wonder on 05 Jul 2024
Tagrisso with the addition of chemotherapy approved in the EU as new first-line treatment for patients with EGFR-mutated advanced lung cancer
5 July 2024 - Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 03 Jul 2024
Johnson & Johnson receives approval from US FDA and European Commission for Sirturo (bedaquiline)
2 July 2024 - Johnson & Johnson announced today that the US FDA has issued traditional approval for Sirturo (bedaquiline) ...
Posted by Michael Wonder on 03 Jul 2024
Dupixent (dupilumab) approved in the European Union as the first ever targeted therapy for patients with COPD
3 July 2024 - First in world approval of Dupixent for adults with uncontrolled COPD with raised blood eosinophils based on ...
Posted by Michael Wonder on 02 Jul 2024
Altos Biologics files for approval of aflibercept biosimilar
1 July 2024 - Alteogen announced on 1 July that its subsidiary, Altos Biologics submitted a marketing authorisation application to ...
Posted by Michael Wonder on 02 Jul 2024
Idorsia’s Jeraygo (aprocitentan) approved in Europe as first and only ERA for the treatment of resistant hypertension
1 July 2024 - Jeraygo is a new oral antihypertensive therapy – the first in almost 40 years – that is ...
Posted by Michael Wonder on 02 Jul 2024
Pierre Fabre Laboratories announce granting of European marketing authorisation for Obgemsa (vibegron) in overactive bladder
28 June 2024 - The European Commission has authorised the marketing of Obgemsa (vibegron) by Pierre Fabre Laboratories for the symptomatic ...
Posted by Michael Wonder on 02 Jul 2024
Valneva receives marketing authorisation in Europe for the world’s first chikungunya vaccine Ixchiq
1 July 2024 - 2024 – Valneva today announced that the European Commission has granted marketing authorisation in Europe for Valneva’s ...
Posted by Michael Wonder on 01 Jul 2024
CHMP recommends EU approval of Roche’s PiaSky for people with PNH, a rare, life-threatening blood condition
28 June 2024 - The recommendation is based on the COMMODORE 2 study results, where SC PiaSky given every month demonstrated ...
Posted by Michael Wonder on 01 Jul 2024
Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
1 July 2024 - Submission based on positive SUPERNOVA Phase 3 trial data which demonstrated a statistically significant reduction in ...
Posted by Michael Wonder on 01 Jul 2024
Lynparza and Imfinzi combination recommended for approval in the EU by CHMP for patients with mismatch repair proficient advanced or recurrent endometrial cancer
1 July 2024 - Recommendation based on DUO-E Phase 3 results, which showed both regimens demonstrated statistically significant and clinically ...
Posted by Michael Wonder on 30 Jun 2024
Roche’s Vabysmo gets CHMP recommendation for third indication retinal vein occlusion
28 June 2024 - Positive recommendation is based on two Phase 3 studies. In addition to robust retinal drying with Vabysmo, ...