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RSS FeedPosted by Michael Wonder on 01 Oct 2020
Genetron Health receives U.S. FDA breakthrough device designation for its blood based NGS test for early detection of hepatocellular carcinoma
30 September 2020 - Genetron Holdings today announced that its blood-based next-generation sequencing test, HCCscreen, has been granted breakthrough device designation ...
Posted by Michael Wonder on 01 Oct 2020
Kadmon announces submission of new drug application to the U.S. FDA for belumosudil in patients with chronic graft versus host disease
30 September 2020 - Application being reviewed under FDA's Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 29 Sep 2020
Infinity receives fast track designation for eganelisib in combination with a checkpoint inhibitor and chemotherapy for first-line treatment of advanced triple negative breast cancer
29 September 2020 - Infinity Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for eganelisib (IPI-549) ...
Posted by Michael Wonder on 27 Sep 2020
Precision BioSciences receives fast track designation from U.S. FDA for PBCAR269A, an investigational allogeneic CAR-T therapy for relapsed/refractory multiple myeloma
9 September 2020 - Precision BioSciences today announced the U.S. FDA has granted fast track designation to PBCAR269A for the treatment ...
Posted by Michael Wonder on 26 Sep 2020
FDA grants rare paediatric disease designation to volasertib for rhabdomyosarcoma
25 September 2020 - Oncoheroes Biosciences is pleased to announce that the United States FDA has granted the designation of rare ...
Posted by Michael Wonder on 26 Sep 2020
RemeGen announces US FDA has granted breakthrough therapy designation for disitamab vedotin (RC48) in urothelial cancer
25 September 2020 - RemeGen today announced that the U.S. FDA has granted Breakthrough Therapy designation for disitamab vedotin (RC48), a ...
Posted by Michael Wonder on 24 Sep 2020
Leap Therapeutics announces FDA fast track designation granted to DKN-01 for the treatment of gastric and gastro-esophageal junction cancer
24 September 2020 - Leap Therapeutics today announced that the U.S. FDA has granted fast track designation to DKN-01 for the ...
Posted by Michael Wonder on 23 Sep 2020
FDA accepts supplemental new drug application for Pfizer’s Xalkori (crizotinib) for the treatment of paediatric ALK positive anaplastic large cell lymphoma
23 September 2020 - If approved, Xalkori would be the first biomarker driven therapy for paediatric ALK positive anaplastic large cell ...
Posted by Michael Wonder on 22 Sep 2020
U.S. FDA accepts for priority review Bristol Myers Squibb and bluebird bio application for anti-BCMA CAR T-cell therapy idecabtagene vicleucel (Ide-cel, bb2121)
22 September 2020 - Ide-cel is the first CAR T cell therapy accepted for regulatory review for multiple myeloma. ...
Posted by Michael Wonder on 22 Sep 2020
ADC Therapeutics submits biologics license application to the U.S. FDA for loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma
21 September 2020 - Submission based on efficacy and safety data from LOTIS 2 clinical trial. ...
Posted by Michael Wonder on 19 Sep 2020
Agenus initiates rolling BLA submission of balstilimab for recurrent/metastatic cervical cancer
18 September 2020 - Agenus announced the initiation of the rolling submission of its biologics license application to the U.S. FDA ...
Posted by Michael Wonder on 17 Sep 2020
Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer
16 September 2020 - Next generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly ...
Posted by Michael Wonder on 16 Sep 2020
FDA granted paediatric disease designation for OXi-4503
16 September 2020 - Treatment of acute myeloid leukaemia due to genetic mutations that disproportionately affect paediatric patients. ...
Posted by Michael Wonder on 15 Sep 2020
Gilead’s magrolimab, an investigational anti-CD47 monoclonal antibody, receives FDA breakthrough therapy designation for treatment of myelodysplastic syndrome
15 September 2020 - On-going clinical program includes the Phase 3 ENHANCE trial in myelodysplastic syndrome. ...
Posted by Michael Wonder on 15 Sep 2020
Plus Therapeutics receives fast track designation from FDA for its novel glioblastoma treatment
15 September 2020 - Plus Therapeutics today announced that the U.S. FDA has granted the Company fast track designation for its ...