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RSS FeedPosted 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
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 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 24 Jul 2020
Sarepta Therapeutics receives fast track designation for SRP-9001 micro-dystrophin gene therapy for the treatment of Duchenne muscular dystrophy
24 July 2020 - Sarepta Therapeutics today announced that the U.S. FDA has granted fast track designation to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin). ...
Posted by Michael Wonder on 24 Jul 2020
FDA grants fast track designation for Hanmi LAPS triple agonist
22 July 2020 - Hanmi Pharmaceutical announced on July 16th that its LAPS Triple Agonist (HM15211), an innovative new drug for ...
Posted by Michael Wonder on 17 Jul 2020
FDA grants fast track designation for DB102 in patients with newly diagnosed glioblastoma
17 July 2020 - Denovo Biopharma today announced that the U.S. FDA has granted fast track designation for DB102 (enzastaurin) being ...
Posted by Michael Wonder on 16 Jul 2020
Farxiga granted fast track designation in the US for heart failure following acute myocardial infarction leveraging an innovative registry-based trial design
16 July 2020 - Phase III DAPA-MI trial will evaluate Farxiga as a treatment to reduce mortality and the risk of ...
Posted by Michael Wonder on 16 Jul 2020
Hanmi’s fatty liver drug won FDA’s fast track designation
16 July 2020 - Hanmi Pharmaceutical said Thursday that the U.S. FDA has granted fast-track designation to its LAPSTriple Agonist ...
Posted by Michael Wonder on 13 Jul 2020
Pfizer and BioNTech granted FDA fast track designation for two investigational mRNA-based vaccine candidates against SARS-CoV-2
13 July 2020 - Anticipated large, global Phase 2b/3 safety and efficacy study may begin as early as July 2020. ...
Posted by Michael Wonder on 09 Jul 2020
Assembly Biosciences announces FDA fast track designation granted to ABI-H2158 for the treatment of chronic hepatitis B virus infection
9 July 2020 - Assembly Biosciences today announced that the U.S. FDA has granted fast track designation to ABI-H2158 (2158) for ...
Posted by Michael Wonder on 03 Jul 2020
MetVital announces FDA fast track designation of anhydrous enol-oxaloacetate for the treatment of patients with newly diagnosed glioblastoma multiforme
1 July 2020 - MetVital today announces that the U.S. FDA has notified MetVital that its lead drug candidate, "Anhydrous ...
Posted by Michael Wonder on 01 Jul 2020
Sun BioPharma receives FDA fast track designation for SBP-101
30 June 2020 - Sun BioPharma today announced receipt of fast track designation from the U.S. FDA for its lead product, ...
Posted by Michael Wonder on 30 Jun 2020
Nordic Nanovector's Betalutin receives fast track designation from US FDA for marginal zone lymphoma
29 June 2020 - Nordic Nanovector today announces that the US FDA has granted fast track designation for investigating Betalutin (177Lu ...
Posted by Michael Wonder on 24 Jun 2020
NeuroRx and Relief Therapeutics announce fast track designation granted by the FDA to RLF-100 (aviptadil) for the treatment of respiratory distress in COVID-19
24 June 2020 - At the FDA’s request, NeuroRx is submitting an expanded access policy enabling physicians to request RLF-100 for ...