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RSS FeedPosted by Michael Wonder on 12 May 2020
Moderna receives FDA fast track designation for mRNA vaccine (mRNA-1273) against novel voronavirus
12 May 2020 - Finalizing protocol for Phase 3 study of mRNA-1273, expected to begin in early summer of 2020. ...
Posted by Michael Wonder on 08 May 2020
FDA grants fast track designation for omecamtiv mecarbil in heart failure
8 May 2020 - Fast track designation highlights the urgent need for new heart failure treatment options. ...
Posted by Michael Wonder on 07 May 2020
Ascentage Pharma's core drug candidate HQP1351 granted fast track designation by the US FDA, marking another milestone in its development
7 May 2020 - Ascentage Pharma today announced that the US FDA has granted HQP1351, the Company's core drug candidate, a ...
Posted by Michael Wonder on 06 May 2020
Cabaletta Bio receives FDA fast track designation for DSG3-CAART for the treatment of mucosal pemphigus vulgaris
6 May 2020 - Cabaletta Bio today announced that the U.S. FDA has granted fast track designation for DSG3-CAART (Desmoglein 3 ...
Posted by Michael Wonder on 05 May 2020
GeneTx and Ultragenyx announce GTX-102 granted fast track designation by US FDA for treatment of Angelman syndrome
4 May 2020 - GeneTx Biotherapeutics and Ultragenyx today announced that the U.S. FDA has granted fast track designation to GTX-102 ...
Posted by Michael Wonder on 29 Apr 2020
FDA grants Carmell Therapeutics expedited review for CT-101, bone healing accelerant
27 April 2020 - Carmell to begin enrolling in pivotal clinical program for first-of-its-kind plasma-based bioactive material product used in long-bone ...
Posted by Michael Wonder on 29 Apr 2020
Erytech Pharma granted U.S. FDA fast track designation for eryaspase in second-line pancreatic cancer
28 April 2020 - Fast track designation for eryaspase underscores the urgent need for potential new treatment options for patients with ...
Posted by Michael Wonder on 28 Apr 2020
A new FDA fast track designation for Zambon
28 April 2020 - The designation is for L‑CsA‑i for the treatment of bronchiolitis obliterans syndrome, developed by Breath Therapeutics, a ...
Posted by Michael Wonder on 22 Apr 2020
Wockhardt receives US FDA qualified infectious disease product designation for WCK 6777, a first ever once-a-day β-lactam enhancer class antibiotic
20 April 2020 - WCK 6777 is a once-a-day combination antibiotic based on Wockhardt’s NCE zidebactam, which imparts WCK 6777 ...
Posted by Michael Wonder on 17 Apr 2020
Chi-Med announces surufatinib granted U.S. FDA fast track designations for the treatment of both pancreatic and non-pancreatic neuroendocrine tumours
17 April 2020 - Hutchison China MediTech today announces that the U.S. FDA has granted two fast track designations for the ...
Posted by Michael Wonder on 16 Apr 2020
FDA grants fast track designation to RemeGen's telitacicept as a treatment for systemic lupus erythematosus
15 April 2020 - RemeGen today announced that the US FDA granted fast track designation for RC18, a novel recombinant TACI-Fc ...
Posted by Michael Wonder on 14 Apr 2020
LifeMax receives fast track designation for LM-030 for the treatment of Netherton syndrome
14 April 2020 - LifeMax Laboratories today announced that the FDA granted fast track designation to LM-030, an investigational therapy licensed ...
Posted by Michael Wonder on 14 Apr 2020
Alnylam receives fast track designation for vutrisiran for the treatment of the polyneuropathy of hATTR amyloidosis
14 April 2020 - Alnylam Pharmaceuticals announced today that the U.S. FDA has granted fast track designation to vutrisiran, an ...
Posted by Michael Wonder on 10 Apr 2020
EicOsis EC5026 granted fast track designation by FDA for neuropathic pain
9 April 2020 - EicOsis LLC, a pharmaceutical startup developing a new class of oral non-narcotic analgesics based on inhibition of ...
Posted by Michael Wonder on 08 Apr 2020
Agenus receives fast track designation for balstilimab in advanced cervical cancer
7 April 2020 - Agenus today announced that the U.S. FDA has granted Agenus fast track designation for investigation of balstilimab ...