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RSS FeedPosted by Michael Wonder on 26 Nov 2025
FDA grants fast track designation to Cothera Bioscience’s zotiraciclib for treatment of recurrent high grade glioma with IDH1/2 mutations
26 November 2025 - Cothera Bioscience today announced that the US FDA has granted fast track designation to zotiraciclib (ZTR/TG02) for ...
Posted by Michael Wonder on 26 Nov 2025
Hundreds could benefit from life saving blood cancer treatment recommended by NICE
25 November 2025 - People with a rare and aggressive blood cancer will benefit from a potentially life saving treatment, following ...
Posted by Michael Wonder on 25 Nov 2025
FDA approves durvalumab for resectable gastric or gastro-oesophageal junction adenocarcinoma
25 November 2025 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as ...
Posted by Michael Wonder on 25 Nov 2025
Avenzo Therapeutics granted fast track designation for AVZO-103, a potential best in class nectin4/TROP2 bispecific antibody drug conjugate, for the treatment of patients with urothelial cancer previously treated with enfortumab vedotin
24 November 2025 - Avenzo Therapeutics today announced the US FDA granted fast track designation to AVZO-103, a potential best ...
Posted by Michael Wonder on 24 Nov 2025
Bristol Myers Squibb receives approval from the European Commission to expand use of CAR T cell therapy Breyanzi for relapsed or refractory mantle cell lymphoma
24 November 2025 - In the TRANSCEND MCL trial, 82.7% of patients responded to Breyanzi, with 71.6% of patients achieving complete ...
Posted by Michael Wonder on 21 Nov 2025
FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer
21 November 2025 - Today, the FDA approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with ...
Posted by Michael Wonder on 21 Nov 2025
Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics initiate rolling submission of new drug application to US FDA for zipalertinib for treatment of locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
20 November 2025 - Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics today announced the companies have initiated the rolling submission ...
Posted by Michael Wonder on 20 Nov 2025
Nuvalent announces FDA acceptance of new drug application for zidesamtinib for the treatment of TKI pre-treated patients with advanced ROS1 positive NSCLC
19 November 2025 - Nuvalent today announced the US FDA has accepted for filing its new drug application for zidesamtinib, ...
Posted by Michael Wonder on 19 Nov 2025
Libtayo (cemiplimab) approved in the European Union as first and only immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma with high risk of recurrence after surgery and radiation
19 November 2025 - Approval based on results of landmark Phase 3 C-POST trial that show Libtayo is first immunotherapy to ...
Posted by Michael Wonder on 19 Nov 2025
FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer
19 November 2025 - Today, the FDA granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage ...
Posted by Michael Wonder on 19 Nov 2025
FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
19 November 2025 - Today, the FDA granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals), a kinase inhibitor, for ...
Posted by Michael Wonder on 19 Nov 2025
FDA grants traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis
19 November 2025 - Today, the FDA granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) with bortezomib, ...
Posted 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 ...