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RSS FeedPosted by Michael Wonder on 01 Feb 2024
Biosyngen announces FDA fast track designation for BST02 in treatment of liver cancer
1 February 2024 - Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted fast track designation ...
Posted by Michael Wonder on 01 Feb 2024
Adaptimmune announces US FDA acceptance of biologics license application for afami-cel for the treatment of advanced synovial sarcoma with priority review
31 January 2024 - Adaptimmune Therapeutics today announced that the US FDA has accepted for priority review its biologics license application ...
Posted by Michael Wonder on 01 Feb 2024
BioNTech and DualityBio receive FDA fast track designation for next generation antibody drug conjugate candidate BNT325/DB-1305
31 January 2024 - Designation is based on preliminary safety and efficacy data from an on-going Phase 1/2 trial in patients ...
Posted by Michael Wonder on 31 Jan 2024
Johnson & Johnson submits supplemental biologics license application to US FDA seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj)-based regimen for the treatment of patients with transplant eligible, newly diagnosed multiple myeloma
30 January 2024 - Data supporting the application showed the addition of Darzalex Faspro to lenalidomide, bortezomib and dexamethasone induction and ...
Posted by Michael Wonder on 30 Jan 2024
Regulatory applications accepted in the US and Japan for Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) in relapsed or refractory follicular lymphoma and relapsed or refractory mantle cell lymphoma
30 January 2024 - US FDA grants both follicular lymphoma and mantle cell lymphoma applications priority review. ...
Posted by Michael Wonder on 29 Jan 2024
Enhertu granted priority review in the US for patients with metastatic HER2 positive solid tumours
29 January 2024 - Application based on results from DESTINY-PanTumor02 trial and supported by additional Enhertu data. ...
Posted by Michael Wonder on 24 Jan 2024
US FDA seeks 'boxed warning' for CAR-T cancer therapies
22 January 2024 - The US health regulator on Monday asked a host of drug makers, including Gilead Sciences, Johnson ...
Posted by Michael Wonder on 24 Jan 2024
UroGen initiates submission of a rolling NDA to the FDA for UGN-102
24 January 2024 - UroGen Pharma today announced the submission of the Chemistry, Manufacturing, and Controls section of the new drug ...
Posted by Michael Wonder on 23 Jan 2024
Autolus Therapeutics announces acceptance of biologics license application for obecabtagene autoleucel as a potential treatment for relapsed/refractory adult B-cell acute lymphoblastic leukaemia
22 January 2024 - PDUFA goal date is 16 November 2024. ...
Posted by Michael Wonder on 19 Jan 2024
FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma
19 January 2024 - Today, the FDA approved erdafitinib (Balversa, Janssen Biotech) for adult patients with locally advanced or metastatic ...
Posted by Michael Wonder on 18 Jan 2024
Verastem Oncology granted fast track designation for combination of avutometinib and sotorasib for the treatment of KRAS G12C mutant non-small-cell lung cancer
18 January 2024 - On-going RAMP 203 trial assessing a more complete vertical blockade with RAF/MEK and KRAS G12C inhibition along ...
Posted by Michael Wonder on 16 Jan 2024
Nurix Therapeutics receives US FDA fast track designation for NX-5948 for the treatment of relapsed or refractory CLL and SLL
16 January 2024 - Fast track designation follows positive Phase 1 data presented at the American Society of Hematology that supports ...
Posted by Michael Wonder on 14 Jan 2024
RemeGen's RC88 obtained FDA fast track designation, heralds new hope for ovarian cancer patients
12 January 2024 - RemeGen announced recently that its independently developed mesothelin targeting antibody drug conjugate RC88 has been granted fast ...
Posted by Michael Wonder on 14 Jan 2024
Shorla Oncology announces FDA filing acceptance of new drug application for novel formulation to treat breast and ovarian cancer
9 January 2024 - Shorla Oncology announced today that the US FDA has accepted for review the company’s new drug application ...
Posted by Michael Wonder on 14 Jan 2024
FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 stage III-IVA cervical cancer
15 January 2024 - On 12 January 2024, the FDA approved pembrolizumab (Keytruda) with chemoradiotherapy for patients with FIGO 2014 stage ...