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RSS FeedPosted by Michael Wonder on 25 Nov 2020
FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow
25 November 2020 - On 24 November 2020, the FDA granted accelerated approval to naxitamab (Danyelza, Y-mAbs Therapeutics) in combination with ...
Posted by Michael Wonder on 25 Nov 2020
RhoVac's prostate cancer drug candidate RV001 is granted fast track designation by the FDA
25 November 2020 - RhoVac, a clinical stage company today announced that the American FDA has granted Fast Track Designation to ...
Posted by Michael Wonder on 24 Nov 2020
Telix new drug application for prostate cancer imaging product accepted by US FDA
24 November 2020 - Telix Pharmaceuticals announces new drug application for TLX591-CDx. ...
Posted by Michael Wonder on 23 Nov 2020
Catalent signs commercial supply agreement with Blueprint Medicines following FDA approval of Gavreto (pralsetinib)
23 November 2020 - Catalent today announced that it had entered into a commercial supply agreement with Blueprint Medicines following FDA ...
Posted by Michael Wonder on 21 Nov 2020
ADC Therapeutics announces FDA accepts biologics license application and grants priority review for loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma
20 November 2020 - Prescription Drug User Fee Act target action date of 21 May 2021. ...
Posted by Michael Wonder on 20 Nov 2020
Imfinzi approved in the US for less-frequent, fixed-dose use
20 November 2020 - Four-week dosing now approved in all Imfinzi indications, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 20 Nov 2020
FDA grants breakthrough designation to 4D Path for novel cancer diagnostic solution
18 November 2020 - 4D Path today announced that the U.S. FDA has granted the company breakthrough device designation for ...
Posted by Michael Wonder on 20 Nov 2020
Lumicell granted fast track designation approval by the FDA for breast cancer treatment
18 November 2020 - Fast track designation augments previously granted breakthrough device designation. ...
Posted by Michael Wonder on 17 Nov 2020
Bristol Myers Squibb provides regulatory update on lisocabtagene maraleucel
16 November 2020 - Bristol-Myers Squibb today announced that the U.S. FDA has informed the company that its review of ...
Posted by Michael Wonder on 15 Nov 2020
Agilent receives expanded FDA approval for PD-L1 IHC 22C3 pharmDx in triple negative breast cancer
13 November 2020 - Announcement marks the seventh cancer type for which PD-L1 IHC 22C3 pharmDx has gained approval in the ...
Posted by Michael Wonder on 13 Nov 2020
FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer
13 November 2020 - Today, the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) in combination with chemotherapy for the ...
Posted by Michael Wonder on 12 Nov 2020
Janssen submits applications in U.S. and EU seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj)/Darzalex (daratumumab) subcutaneous formulation in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma
12 November 2020 - Applications supported by positive results from the Phase 3 APOLLO trial, which demonstrated longer progression-free survival in ...
Posted by Michael Wonder on 11 Nov 2020
Surface Oncology announces FDA fast track designation granted by U.S. Food and Drug Administration for SRF388 to treat liver cancer
11 November 2020 - Surface Oncology today announced that the U.S. FDA has granted fast track designation to SRF388 for ...
Posted by Michael Wonder on 10 Nov 2020
Rafael Pharmaceuticals receives FDA fast track designation for CPI-613 (devimistat) for the treatment of pancreatic cancer
10 November 2020 - Rafael Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 09 Nov 2020
FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers
9 November 2020 - On 6 November, the FDA approved the FoundationOne Liquid CDx test as a companion diagnostic device to ...