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RSS FeedPosted by Michael Wonder on 29 Jul 2020
Alzheimer's: 'promising' blood test for early stage of disease
29 July 2020 - A blood test could spot Alzheimer's disease at the earliest stage and years before symptoms appear, ...
Posted by Michael Wonder on 29 Jul 2020
FDA approves Roche’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy
29 July 2020 - Developed with enhanced technology, this new assay provides high-quality staining with improved turnaround time. ...
Posted by Michael Wonder on 29 Jul 2020
Protara Therapeutics receives rare paediatric disease designation for TARA-002 for the treatment of lymphatic malformations
28 July 2020 - Protara Therapeutics today announced that the U.S. FDA has granted rare paediatric disease designation for TARA-002 for ...
Posted by Michael Wonder on 29 Jul 2020
BioMed Valley Discoveries’ ulixertinib (BVD-523), a first-in-class ERK inhibitor cancer therapy, receives fast track designation and launches Phase II trial in collaboration with Cmed and Strata Oncology
28 July 2020 - BioMed Valley Discoveries announces the receipt of fast track designation from the US FDA for investigation of ...
Posted by Michael Wonder on 28 Jul 2020
HemoShear Therapeutics receives FDA fast track and rare paediatric disease designations for HST5040 to treat methylmalonic acidaemia and propionic acidaemia
28 July 2020 - HemoShear Therapeutics has received fast track and rare paediatric disease designations from the U.S. FDA for ...
Posted by Michael Wonder on 28 Jul 2020
Momenta Pharmaceuticals announces FDA rare paediatric disease designation for nipocalimab in HDFN
28 July 2020 - Momenta Pharmaceuticals today announced that its novel drug candidate, nipocalimab, has received rare paediatric disease designation ...
Posted by Michael Wonder on 28 Jul 2020
Black Diamond Therapeutics granted fast track designation by the FDA for BDTX-189 for the treatment of adult patients with a solid tumour harbouring an allosteric HER2 mutation or an EGFR or HER2 exon 20 insertion mutation
28 July 2020 - Black Diamond Therapeutics today announced that the U.S. FDA granted fast track designation to BDTX-189 for the ...
Posted by Michael Wonder on 28 Jul 2020
Foresee Pharmaceuticals announces submission of NDA for FDA approval of LMIS 50 mg
27 July 2020 - Foresee Pharmaceuticals announced today that it has submitted to the U.S. FDA a new drug application ...
Posted by Michael Wonder on 28 Jul 2020
Lumos Pharma announces sale of priority review voucher
27 July 2020 - ) -- Lumos Pharma today announced that it has entered into a definitive agreement to sell ...
Posted by Michael Wonder on 28 Jul 2020
Dr. Reddy's Laboratories received approval of Xeglyze (abametapir) 0.74% lotion in the U.S.
27 July 2020 - Dr. Reddy’s Laboratories today announced approval of Xeglyze (abametapir) 0.74% topical lotion, new drug application by the ...
Posted by Michael Wonder on 27 Jul 2020
scPharmaceuticals announces FDA acceptance of Furoscix new drug application resubmission
27 July 2020 - FDA sets PDUFA date of 30 December 2020. ...
Posted by Michael Wonder on 27 Jul 2020
Eton Pharmaceuticals submits new drug application to the FDA for orphan drug dehydrated alcohol injection
27 July 2020 - Since the start of COVID-19, the FDA has recalled more than 75 contaminated hand sanitisers due to ...
Posted by Michael Wonder on 27 Jul 2020
Checkmate Pharmaceuticals granted FDA fast track designation for CMP-001 combined with PD-1 blockade in the treatment of certain types of metastatic or unresectable melanoma
27 July 2020 - Checkmate Pharmaceuticals today announced that the U.S. FDA granted fast track designation to its product candidate, ...
Posted by Michael Wonder on 25 Jul 2020
Breztri Aerosphere approved in the US for the maintenance treatment of COPD
24 July 2020 - Approval based on Phase III ETHOS trial which showed a statistically significant reduction in the rate of ...
Posted by Michael Wonder on 24 Jul 2020
FDA approves first cell-based gene therapy for adult patients with relapsed or refractory mantle cell lymphoma
24 July 2020 - Today, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment ...