Blog
RSS FeedPosted by Michael Wonder on 09 Aug 2025
Imfinzi approved in Canada as first and only peri-operative immunotherapy for muscle invasive bladder cancer
6 August 2025 - Health Canada has granted a Notice of Compliance for Imfinzi (durvalumab) for the treatment of patients ...
Posted by Michael Wonder on 09 Aug 2025
International study on authorisation times confirms Swissmedic's competitiveness
6 August 2025 - Latest CIRS study rates Swissmedic's authorisation procedures for human medicinal products with new active substances as internationally ...
Posted by Michael Wonder on 09 Aug 2025
Medicines for chronic illnesses soon accessible before European authorisation
7 August 2025 - The scheme will be launched on 1 January 2026 and is expected to provide access to ...
Posted by Michael Wonder on 09 Aug 2025
Health Canada has authorised CSL's Andembry (garadacimab) as once monthly treatment for hereditary angioedema
8 August 2025 - CSL today announced that Health Canada has granted a marketing authorisation for Andembry (garadacimab) for routine ...
Posted by Michael Wonder on 09 Aug 2025
Arvinas announces FDA acceptance of the new drug application for vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer
8 August 2025 - Filing based on pivotal Phase 3 VERITAC-2 clinical trial demonstrating statistically significant and clinically meaningful improvement in ...
Posted by Michael Wonder on 08 Aug 2025
FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations
8 August 2025 - Today, the FDA granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals), a kinase inhibitor, for ...
Posted by Michael Wonder on 08 Aug 2025
FDA approves expanded indication for Avtozma (tocilizumab-anoh) intravenous formulation in cytokine release syndrome
6 August 2025 - Approval of Avtozma (tocilizumab-anoh) intravenous infusion expands label to include treatment of adults and paediatric patients aged ...
Posted by Michael Wonder on 06 Aug 2025
Galapagos announces US FDA regenerative medicine advanced therapy designation granted to GLPG5101 for the treatment of relapsed/refractory mantle cell lymphoma
6 August 2025 - Galapagos today announced that the US FDA has granted RMAT designation to GLPG5101, a second generation anti-CD19/4-1BB ...
Posted by Michael Wonder on 06 Aug 2025
The US FDA granted fast track designation to Dizal's birelentinib for relapsed/refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
6 August 2025 - Supporting data from a pooled analysis of Phase I/II studies of birelentinib showed an objective response ...
Posted by Michael Wonder on 06 Aug 2025
FDA grants accelerated approval to dordaviprone for diffuse midline glioma
6 August 2025 -Today, the FDA granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals), a protease activator, for adult and ...
Posted by Michael Wonder on 06 Aug 2025
Kye Pharmaceuticals announces the approval of Dynavel XR (amphetamine extended release) tablets and oral suspension for the treatment of adults and children with ADHD
5 August 2025 - Kye Pharmaceuticals is pleased to announce the Health Canada approval (notice of compliance) for Dyanavel XR ...
Posted by Michael Wonder on 04 Aug 2025
Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) accepted for priority review by US FDA in fifth cancer type for relapsed or refractory marginal zone lymphoma
4 August 2025 - Bristol Myers Squibb today announced that the US FDA has accepted the supplemental biologics license application ...
Posted by Michael Wonder on 04 Aug 2025
Clarametyx Biosciences announces FDA grant of fast track and qualified infectious disease product designations for CMTX-101
4 August 2025 - Clarametyx Biosciences today announced that the US FDA has granted fast track and qualified infectious disease ...
Posted by Michael Wonder on 04 Aug 2025
Dyne Therapeutics announces FDA breakthrough therapy designation for DYNE-251 in Duchenne muscular dystrophy
4 August 2025 - Dyne Therapeutics today announced that the US FDA has granted breakthrough therapy designation to DYNE-251 for ...
Posted by Michael Wonder on 02 Aug 2025
Update on US regulatory review of supplemental biologics license application
1 August 2025 - The US FDA issued a complete response letter for the supplemental biologics license application for Darzalex ...