Blog
RSS FeedPosted 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 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
Health Canada expands approval of Scemblix, making it an option for newly diagnosed and previously treated chronic myeloid leukaemia patients
30 July 2025 - Scemblix is first to show superior efficacy and a favourable safety and tolerability profile in a Phase ...
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 29 Jul 2025
BeOne Medicines receives positive CHMP opinion for Tevimbra in neo-adjuvant/adjuvant NSCLC treatment
28 July 2025 - Recommendation based on Phase 3 RATIONALE-315 study, in which Tevimbra demonstrated clinically meaningful and statistically significant improvement ...
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 26 Jul 2025
Sanofi’s Sarclisa approved in the EU for the treatment of transplant-eligible newly diagnosed multiple myeloma
25 July 2025 - Approval based on GMMG-HD7 Phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD ...
Posted by Michael Wonder on 25 Jul 2025
Cabometyx approved in the EU for previously treated advanced neuroendocrine tumours
24 July 2025 - Approval based on pivotal CABINET Phase 3 trial which demonstrated a 77% and 62% reduction in ...
Posted by Michael Wonder on 25 Jul 2025
Blenrep (belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma
24 July 2025 - Two head-to-head Phase 3 trials demonstrated superior efficacy, including overall survival versus a daratumumab-based triplet in DREAMM-7. ...
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, ...