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RSS FeedPosted 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 ...
Posted by Michael Wonder on 01 Aug 2025
FDA approves Alhemo as once daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with haemophilia A or B without inhibitors
31 July 2025 - FDA approval is based on phase 3 trial data (explorer8), which established the safety and efficacy of ...
Posted by Michael Wonder on 01 Aug 2025
BeOne Medicines receives PRIME designation from the EMA for BGB-16673 in Waldenström’s macroglobulinaemia
31 July 2025 - Decision highlights the promise of BGB-16673, an investigational and potentially first in class BTK degrader designed ...
Posted by Michael Wonder on 01 Aug 2025
Atara Biotherapeutics announces US FDA acceptance and priority review of the biologics license application for tabelecleucel (tab-cel) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
24 July 2025 - PDUFA target action date of 10 January 2026. ...
Posted by Michael Wonder on 01 Aug 2025
Lenz Therapeutics announces US FDA approval of Vizz for the treatment of presbyopia
31 July 2025 - Vizz samples and product availability in the US expected as early as October 2025. ...
Posted by Michael Wonder on 01 Aug 2025
Novartis twice yearly Leqvio (inclisiran) receives FDA approval for new indication enabling first-line use
31 July 2025 - 4 out of 5 atherosclerotic cardiovascular disease patients do not reach guideline-recommended LDL-C target, reinforcing urgent need ...
Posted by Michael Wonder on 01 Aug 2025
US FDA approves new Biktarvy indication for people with HIV who are treatment experienced and restarting antiretroviral treatment
30 July 2025 - Gilead Sciences today announced that the US FDA has granted a new approval for a novel ...
Posted by Michael Wonder on 31 Jul 2025
Revalesio receives FDA fast track designation for RNS60 for the treatment of acute ischaemic stroke
31 July 2025 - Revalesio today announced that the US FDA has granted fast track designation to RNS60, its lead investigational ...
Posted by Michael Wonder on 31 Jul 2025
EMA CHMP adopts positive opinion recommending authorisation of Moderna's COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant LP.8.1
25 July 2025 - Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European ...