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RSS FeedPosted by Michael Wonder on 19 Nov 2025
European Commission approves Roche’s Lunsumio subcutaneous for relapsed or refractory follicular lymphoma
19 November 2025 - Roche announced today that the European Commission has granted conditional marketing authorisation of Lunsumio (mosunetuzumab) subcutaneous for ...
Posted by Michael Wonder on 19 Nov 2025
FDA approves selumetinib for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
19 November 2025 - Today, the FDA approved selumetinib (Koselugo, AstraZeneca Pharmaceuticals) for adults with neurofibromatosis type 1 who have ...
Posted by Michael Wonder on 18 Nov 2025
FDA approves epcoritamab-bysp for follicular lymphoma indications
18 November 2025 - Today, the FDA approved epcoritamab-bysp (Epkinly, Genmab) with lenalidomide and rituximab for relapsed or refractory follicular ...
Posted by Michael Wonder on 18 Nov 2025
Lupron Depot new strength receives Health Canada approval for the treatment of advanced prostate cancer
17 November 2025 - AbbVie announced today that a new 6 month 45 mg Lupron Depot (leuprolide acetate for extended release ...
Posted by Michael Wonder on 17 Nov 2025
Celcuity announces completion of submission of its new drug application to the US FDA for gedatolisib in HR+/HER2-/PIK3CA wild type advanced breast cancer
17 November 2025 - Celcuity today announced the completion of the submission of its new drug application to the US FDA ...
Posted by Michael Wonder on 17 Nov 2025
FDA grants fast track designation to Dewpoint Therapeutics’ DPTX3186 for the treatment of gastric cancer
17 November 2025 - Dewpoint Therapeutics announced today that the US FDA has granted fast track designation to DPTX3186, the company’s ...
Posted by Michael Wonder on 14 Nov 2025
ITM announces FDA acceptance of new drug application and PDUFA date for lutetium Lu 177 edotreotide (ITM-11) in gastro-enteropancreatic neuroendocrine tumours
13 November 2025 - 2025 - ITM Isotope Technologies today announced that the US FDA completed its filing review and accepted ...
Posted by Michael Wonder on 14 Nov 2025
Allterum Therapeutics receives FDA fast track designation for 4A10 in acute lymphoblastic leukaemia
11 November 2025 - Allterum Therapeutics today announced that the US FDA has granted fast track designation for its lead program, ...
Posted by Michael Wonder on 13 Nov 2025
FDA approves Promega OncoMate MSI Dx analysis system as companion diagnostic for Keytruda in combination with Lenvima in advanced endometrial carcinoma
11 November 2025 - The US FDA has approved the Promega OncoMate MSI Dx Analysis System as a companion diagnostic designed ...
Posted by Michael Wonder on 13 Nov 2025
FDA approves ziftomenib for relapsed or refractory acute myeloid leukaemia with a NPM1 mutation
13 November 2025 - Today, the FDA approved ziftomenib (Komzifti, Kura Oncology), a menin inhibitor, for adults with relapsed or ...
Posted by Michael Wonder on 12 Nov 2025
Parabilis Medicines receives FDA fast track designation for FOG-001, the first and only direct inhibitor of the β-catenin:TCF interaction for the treatment of desmoid tumours
12 November 2025 - Parabilis Medicines today announced that the US FDA has granted fast track product designation to FOG-001 ...
Posted by Michael Wonder on 12 Nov 2025
Artios receives US FDA fast track designation for alnodesertib in ATM negative metastatic colorectal cancer
24 September 2025 - Artios Pharma today announced that the US FDA granted fast track designation to its ATR inhibitor, ...
Posted by Michael Wonder on 12 Nov 2025
AstraZeneca’s Imfinzi, Imjudo, and Ultomiris clear reimbursement panel review
7 November 2025 - AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab), the anti-CTLA-4 immune checkpoint inhibitor Imjudo (tremelimumab), and the ...
Posted by Michael Wonder on 10 Nov 2025
Avenzo Therapeutics granted fast track designation for AVZO-1418, a potential best in class EGFR/HER3 bispecific antibody drug conjugate, for the treatment of patients with EGFR mutated TKI pretreated NSCLC
10 November 2025 - Avenzo Therapeutics today announced the US FDA granted fast track designation to AVZO-1418 (DB-1418), a potential ...
Posted by Michael Wonder on 06 Nov 2025
FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma
6 November 2025 - On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) ...