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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 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 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 30 Jul 2025
Calidi Biotherapeutics receives FDA fast track designation for CLD-201 (SuperNova), a first in class stem cell loaded viral therapy for the treatment of patients with soft tissue sarcoma
29 July 2025 - Calidi Biotherapeutics today announced that it received fast track designation from the US FDA for CLD-201 (SuperNova), ...
Posted by Michael Wonder on 29 Jul 2025
AbbVie submits for US FDA approval of combination treatment of Venclexta (venetoclax) and acalabrutinib for previously untreated patients with chronic lymphocytic leukaemia
29 July 2025 - Application is supported by data from the Phase 3 AMPLIFY trial that showed statistically significant improvement in ...
Posted by Michael Wonder on 28 Jul 2025
MAIA Biotechnology receives FDA’s fast track designation for ateganosine as a treatment for non-small cell lung cancer
28 July 2025 - Potential first to market small molecule telomere targeting agent targets a $34 billion non-small cell lung cancer ...
Posted by Michael Wonder on 28 Jul 2025
Imfinzi granted priority review and breakthrough therapy designation in the US for patients with resectable early-stage gastric and gastro-oesophageal junction cancers
28 July 2025 - Based on MATTERHORN Phase 3 trial results which demonstrated a statistically significant and clinically meaningful event-free survival ...
Posted by Michael Wonder on 24 Jul 2025
Verastem Oncology granted fast track designation for VS-7375 for the treatment of KRAS G12D mutated locally advanced or metastatic pancreatic cancer
24 July 2025 - Enrollment is on-going in US Phase 1/2a trial for VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, ...
Posted by Michael Wonder on 24 Jul 2025
Revolution Medicines announces FDA breakthrough therapy designation for elironrasib
23 July 2025 - Designation based on encouraging clinical data observed with elironrasib in patients with advanced KRAS G12C non-small ...
Posted by Michael Wonder on 23 Jul 2025
GSK announces extension of US FDA an review period for Blenrep (belantamab mafodotin-blmf) in relapsed/refractory multiple myeloma
23 July 2025 - New PDUFA date scheduled for 23 October 2025. ...
Posted by Michael Wonder on 23 Jul 2025
DualityBio's next generation HER3 ADC DB-1310 granted FDA fast track designation
21 July 2025 - DualityBio announced that the US FDA has granted fast track designation to its next-generation HER3 targeting antibody ...
Posted by Michael Wonder on 18 Jul 2025
Genentech provides update on supplemental biologics license application for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
18 July 2025 - Genentech announced today that the US FDA issued a complete response letter for Genentech’s supplemental biologics ...
Posted by Michael Wonder on 18 Jul 2025
Johnson & Johnson receives US FDA priority review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer
17 July 2025 - New drug application supported by results from the Phase 2b SunRISe-1 study. ...
Posted by Michael Wonder on 17 Jul 2025
Enhertu plus pertuzumab granted breakthrough therapy designation in the US as first-line therapy for patients with HER2 positive metastatic breast cancer
17 July 2025 - Ninth breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s Enhertu with the latest based on DESTINY-Breast09 ...