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RSS FeedPosted 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 02 Jul 2024
Vertex announces FDA acceptance of new drug application for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis
2 July 2024 - Vanza triple granted priority review with a PDUFA target action date of 2 January 2025. ...
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 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 29 Jun 2024
Iovance Biotherapeutics submits marketing authorisation application to European Medicines Agency for lifileucel in advanced melanoma
28 June 2024 - First of multiple planned global submissions for lifileucel in 2024 and 2025. ...
Posted by Michael Wonder on 27 Jun 2024
Bavarian Nordic submits marketing authorisation application for its chikungunya vaccine candidate to EMA
26 June 2024 - Regulatory review of the single-dose CHIKV VLP vaccine candidate for immunization to prevent disease caused by ...
Posted by Michael Wonder on 25 Jun 2024
Jemperli (dostarlimab) plus chemotherapy application accepted for review by the EMA to expand use to all patients with primary advanced or recurrent endometrial cancer
24 June 2024 - Regulatory submission supported by statistically significant and clinically meaningful progression-free and overall survival data from Part 1 ...
Posted by Michael Wonder on 25 Jun 2024
Novavax submits application to EMA for updated protein-based 2024-2025 formula COVID-19 vaccine
24 June 2024 - Novavax's JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3 ...
Posted by Michael Wonder on 21 Jun 2024
European Medicines Agency validates Bristol Myers Squibb’s application for subcutaneous nivolumab
21 June 2024 - Validation is based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation ...
Posted by Michael Wonder on 05 Jun 2024
Johnson & Johnson submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Prezcobix
4 June 2024 - Johnson & Johnson today announced the submission of a supplemental new drug application to the US FDA ...
Posted by Michael Wonder on 05 Jun 2024
Nidlegy marketing authorisation application submitted to EMA
4 June 2024 - First marketing authorisation submission for Nidlegy for the treatment of locally advanced, fully resectable melanoma in ...
Posted by Michael Wonder on 03 Jun 2024
Johnson & Johnson submits application to the EMA seeking approval of subcutaneous formulation of Rybrevant (amivantamab) for the treatment of patients with EGFR mutated non-small cell lung cancer
31 May 2024 - Submission is supported by data from the Phase 3 PALOMA-3 study featured at the American Society of ...
Posted by Michael Wonder on 30 May 2024
Vyluma announces marketing authorisation application validation for the European Union
29 May 2024 - Vyluma announced today that the EMA has validated the marketing authorisation application for its lead compound, NVK002. ...
Posted by Michael Wonder on 28 May 2024
Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma
27 May 2024 - FDA priority review granted based on positive results from IMROZ Phase 3 study. ...
Posted by Michael Wonder on 25 May 2024
EMA validates Henlius and Organon filings for Prolia and Xgeva (denosumab) biosimilar candidate HLX14
24 May 2024 - Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation applications for ...