Blog
RSS FeedPosted by Michael Wonder on 20 Aug 2020
US FDA awards fast track designation to paxalisib for glioblastoma
20 August 2020 - Kazia Therapeutics is pleased to announce that the United States FDA has granted fast track designation to ...
Posted by Michael Wonder on 18 Aug 2020
Imfinzi granted FDA priority review for less-frequent, fixed-dose use
18 August 2020 - Option would extend dosing to four weeks in non-small cell lung and bladder cancer reducing medical visits ...
Posted by Michael Wonder on 17 Aug 2020
Acute myeloid leukaemia: developing drugs and biological products for treatment
17 August 2020 - The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological ...
Posted by Michael Wonder on 14 Aug 2020
ANTI-PD-1/CTLA-4 bi-specific antibody (AK104) of Akeso granted FDA fast track designation for recurrent and metastatic cervical cancer
13 August 2020 - Akeso today announced that the U.S. FDA has granted fast track designation for AK104, a novel anti-PD-1/CTLA-4 ...
Posted by Michael Wonder on 13 Aug 2020
TG Therapeutics announces FDA acceptance of new drug application for umbralisib as a treatment for patients with previously treated marginal zone lymphoma and follicular lymphoma
13 August 2020 - TG Therapeutics today announced that the U.S. FDA has accepted the Company’s new drug application for umbralisib, ...
Posted by Michael Wonder on 11 Aug 2020
Mersana Therapeutics receives FDA fast track designation for XMT-1536 for the treatment of patients with platinum-resistant ovarian cancer
11 August 2020 - Mersana Therapeutics today announced that the U.S. FDA has granted fast track designation for XMT-1536, for the ...
Posted by Michael Wonder on 07 Aug 2020
FDA approves first liquid biopsy next generation sequencing companion diagnostic test
7 August 2020 - Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses ...
Posted by Michael Wonder on 07 Aug 2020
Y-mAbs announces completion of submission of omburtamab biologics license application to FDA
6 August 2020 - Y-mAbs Therapeutics today announced that on 5 August 2020, the Company completed the submission of its biologics ...
Posted by Michael Wonder on 06 Aug 2020
FDA approves GSK’s Blenrep (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma
6 August 2020 - Blenrep is the fifth major medicine approval for GSK in 2020. ...
Posted by Michael Wonder on 05 Aug 2020
Cerecor receives rare paediatric disease designation for CERC-006 in lymphatic malformations
4 August 2020 - Cerecor today announced that the U.S. FDA granted rare paediatric disease designation to CERC-006, a dual inhibitor ...
Posted by Michael Wonder on 04 Aug 2020
Biosight granted U.S. FDA fast track designation for BST-236 for the treatment of acute myeloid leukaemia
4 August 2020 - Biosight today announced that that the U.S. FDA has granted fast track designation for BST-236 (aspacytarabine) ...
Posted by Michael Wonder on 01 Aug 2020
FDA approves Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma
31 July 2020 - First FDA approval of a second-line treatment for adult patients with relapsed or refractory diffuse large B-cell ...
Posted by Michael Wonder on 31 Jul 2020
Medicare expands coverage for BRACAnalysis CDx in prostate cancer
31 July 2020 - Myriad Genetics announced today that Medicare has expanded coverage for BRACAnalysis CDx for men with prostate cancer ...
Posted by Michael Wonder on 31 Jul 2020
Tagrisso granted breakthrough therapy designation in the US for the adjuvant treatment of patients with Stage IB-IIIA EGFR mutated lung cancer
30 July 2020 - Designation based on unprecedented results from the Phase III ADAURA trial where Tagrisso reduced the risk of ...
Posted by Michael Wonder on 30 Jul 2020
Takeda announces U.S. FDA breakthrough therapy designation granted for pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes
30 July 2020 - Designation based on Phase 2 data and reinforces significant treatment need for higher-risk myelodysplastic syndrome. ...