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RSS FeedPosted by Michael Wonder on 03 Apr 2025
Averoa receives positive opinion from the EMA for Xoancyl, an oral therapy for chronic kidney disease
2 April 2025 - Final European Commission decision expected by June 2025; UK regulatory submission foreseen via MHRA’s international recognition procedure. ...
Posted by Michael Wonder on 02 Apr 2025
Denali Therapeutics announces initiation of BLA filing for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome
2 April 2025 - Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential US commercial launch in late ...
Posted by Michael Wonder on 02 Apr 2025
Biogen’s investigational tau-targeting therapy BIIB080 receives FDA fast track designation for the treatment of Alzheimer’s disease
2 April 2025 - Biogen today announced that the US FDA has granted fast track designation to BIIB080, an investigational ...
Posted by Michael Wonder on 02 Apr 2025
Sydnexis announces positive CHMP opinion in Europe for SYD-101 for slowing the progression of paediatric myopia
1 April 2025 - Santen is Sydnexis’ licensing partner to commercialise SYD-101 within the EMEA region upon issuance of a ...
Posted by Michael Wonder on 02 Apr 2025
Valneva’s chikungunya vaccine Ixchiq now authorised in EU for adolescents aged 12 and above
1 April 2025 - With this extension, Ixchiq, the first vaccine against the chikungunya virus, is now available for administration ...
Posted by Michael Wonder on 02 Apr 2025
Rystiggo now approved for adults with generalised myasthenia gravis in Canada
2 April 2025 - The approval is supported by the pivotal Phase 3 MycarinG study in gMG, which demonstrated that treatment ...
Posted by Michael Wonder on 02 Apr 2025
Apellis announces FDA acceptance and priority review of the supplemental new drug application for Empaveli (pegcetacoplan) for C3G and primary IC-MPGN
1 April 2025 - PDUFA target action date is 28 July 2025. ...
Posted by Michael Wonder on 01 Apr 2025
GRIN Therapeutics receives PRIME designation from EMA for radiprodil in the treatment of GRIN related neurodevelopmental disorder
1 April 2025 - GRIN Therapeutics today announced that the EMA has granted Priority Medicine (PRIME) designation to radiprodil, the company's ...
Posted by Michael Wonder on 01 Apr 2025
Highlights from the 24-27 March 2025 CHMP meeting
28 March 2025 - The EMA’s CHMP recommended five medicines for approval at its March 2025 meeting. ...
Posted by Michael Wonder on 01 Apr 2025
European Commission approves Pfizer’s RSV vaccine Abrysvo to help protect adults aged 18-59 against RSV lower respiratory tract disease
1 April 2025 - Abrysvo is the first and only RSV vaccine approved in the European Union for non-pregnant adults ...
Posted by Michael Wonder on 01 Apr 2025
Vanda Pharmaceuticals announces the submission of an NDA to the FDA for Bysanti for the treatments of acute bipolar I disorder and schizophrenia
31 March 2025 - Vanda Pharmaceuticals today announced that a new drug application was submitted to the US FDA requesting marketing ...
Posted by Michael Wonder on 01 Apr 2025
Tivdak (tisotumab vedotin) approved by European Commission for previously treated recurrent or metastatic cervical cancer
31 March 2025 - In the global Phase 3 innovaTV 301 clinical trial Tivdak demonstrated superior overall survival compared to chemotherapy. ...
Posted by Michael Wonder on 01 Apr 2025
Bavarian Nordic receives US FDA approval of freeze dried smallpox and mpox vaccine
31 March 2025 - Bavarian Nordic today announced that the US FDA has approved the freeze dried formulation of Jynneos (smallpox ...
Posted by Michael Wonder on 31 Mar 2025
IDEAYA Biosciences receives US FDA breakthrough therapy designation for darovasertib monotherapy in neo-adjuvant uveal melanoma
31 March 2025 - Breakthrough therapy application was supported by updated clinical data from Phase 2 neo-adjuvant uveal melanoma trial that ...
Posted by Michael Wonder on 31 Mar 2025
Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for first-line mantle cell lymphoma
31 March 2025 - Recommendation based on ECHO Phase 3 trial results which demonstrated over 16 months of progression-free survival ...