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RSS FeedPosted by Michael Wonder on 19 Jul 2024
Bavarian Nordic receives EMA filing acceptance and validation of the MAA for its chikungunya vaccine
18 July 2024 - EMA will now initiate its centralised review procedure under accelerated assessment for Bavarian Nordic’s chikungunya vaccine. ...
Posted by Michael Wonder on 19 Jul 2024
Atara Biotherapeutics announces US FDA acceptance and priority review of the biologics license application for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
17 July 2024 - PDUFA target action date of 15 January 2025. ...
Posted by Michael Wonder on 19 Jul 2024
Orexo shares new information on OX124, a high dose naloxone rescue medication in development for opioid overdose
16 July 2024 - Orexo today announces that the company has received a complete response letter from the US FDA regarding ...
Posted by Michael Wonder on 18 Jul 2024
Junshi Biosciences announces the acceptance of the supplemental new drug application for toripalimab combined with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma
17 July 2024 - Shanghai Junshi Biosciences announced that the National Medical Products Administration has accepted for review the supplemental new ...
Posted by Michael Wonder on 14 Jul 2024
Fresenius announces EMA validation of marketing authorisation application for denosumab biosimilar candidates
11 July 2024 - Fresenius, via its operating company Fresenius Kabi, announced that the EMA has accepted for review the company’s ...
Posted 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 11 Jul 2024
Novo Nordisk receives complete response letter in the US for once weekly basal insulin icodec
10 July 2024 - Novo Nordisk today announced that the US FDA has issued a complete response letter covering the ...
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 09 Jul 2024
Mesoblast resubmits biologics license application with US FDA for approval of Ryoncil in children with steroid-refractory acute graft versus host disease
8 July 2024 - Mesoblast announced today it has resubmitted its BLA for approval of Ryoncil (remestemcel-L) in the treatment ...
Posted by Michael Wonder on 08 Jul 2024
Besremi retries for insurance coverage promising a potential operational cure
8 July 2024 - Besremi (rofeginterferon alfa-2b), which has recently set a new standard in treating polycythemia vera by offering ...
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 04 Jul 2024
Checkpoint Therapeutics announces biologics license application resubmission for cosibelimab
2 July 2024 - Checkpoint Therapeutics today announced it has completed the resubmission of its biologics license application to the US ...
Posted by Michael Wonder on 04 Jul 2024
Hutchmed announces NDA acceptance in China for tazemetostat for the treatment of relapsed or refractory follicular lymphoma with priority review status
4 July 2024 - - Hutchmed (China) today announces that the new drug application for tazemetostat for the treatment of ...
Posted by Michael Wonder on 03 Jul 2024
Sobi initiates rolling biologics license application to FDA for SEL-212 for the potential treatment of chronic refractory gout
2 July 2024 - Sobi today announced the initiation of a rolling biologics license application to the US FDA for SEL-212. ...