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RSS FeedPosted by Michael Wonder on 08 Nov 2021
Seelos Therapeutics announces FDA grant of fast track designation for SLS-005 (IV trehalose) for the treatment of spinocerebellar ataxia
8 November 2021 - Global Phase IIb/III study for SLS-005 to be initiated in early 2022. ...
Posted by Michael Wonder on 08 Nov 2021
AZ announces US fast track designation for IL-5 inhibitor Fasenra
8 November 2021 - AstraZeneca’s IL-5 inhibitor Fasenra (benralizumab) has received a fast track designation from the US FDA for ...
Posted by Michael Wonder on 04 Nov 2021
Opiant receives FDA fast track designation for OPNT003, nasal nalmefene, for treatment of opioid overdose
4 November 2021 - Fast track designation further underscores the potential for OPNT003 to represent a major advance in the treatment ...
Posted by Michael Wonder on 04 Nov 2021
Lipocine announces FDA grants fast track designation to LPCN 1144 for treatment of non-cirrhotic NASH
4 November 2021 - Lipocine today announced that the U.S. FDA has granted fast track designation to LPCN 1144 as a ...
Posted by Michael Wonder on 04 Nov 2021
UNION therapeutics receives FDA fast track designation for oral orismilast for the treatment of moderate to severe atopic dermatitis
4 November 2021 - FDA's fast track designation for oral orismilast underscores the urgent need for new treatment option with potential ...
Posted by Michael Wonder on 04 Nov 2021
Epizyme receives fast track designation from U.S. FDA and announces initiation of Phase 1/1b study of its novel SETD2 inhibitor, EZM0414
4 November 2021 - Epizyme today announced that the U.S. FDA has granted fast track designation to EZM0414, the Company’s novel, ...
Posted by Michael Wonder on 03 Nov 2021
TransThera receives fast track designation from FDA for its core product TT-00420 to treat cholangiocarcinoma
3 November 2021 - TransThera Sciences announced that the U.S. FDA has granted fast track designation to its phase II ...
Posted by Michael Wonder on 03 Nov 2021
Allena Pharmaceuticals receives fast track designation from FDA for the development of ALLN-346 for chronic treatment of hyperuricemia in patients with gout and advanced chronic kidney disease
3 November 2021 - Novel oral therapeutic candidate ALLN-346 targets uric acid in the intestinal tract. ...
Posted by Michael Wonder on 25 Oct 2021
Alkermes receives FDA fast track designation for nemvaleukin alfa in combination with pembrolizumab for the treatment of platinum-resistant ovarian cancer
26 October 2021 - Second fast track designation for nemvaleukin. ...
Posted by Michael Wonder on 23 Oct 2021
Sio Gene Therapies announces granting of FDA fast track designation for investigational AXO-AAV-GM1 (AAV9-GLB1) gene therapy in patients with GM1 gangliosidosis
21 October 2021 - Sio Gene Therapies today announced that the U.S. FDA has granted fast track designation to AXO-AAV-GM1, its ...
Posted by Michael Wonder on 21 Oct 2021
Ultimovacs receives dual FDA fast track designation for UV1 in advanced malignant melanoma
21 October 2021 - UV1 as add-on therapy to checkpoint inhibitors awarded fast track designation. ...
Posted by Michael Wonder on 19 Oct 2021
Akero Therapeutics receives FDA fast track designation for efruxifermin for the treatment of NASH
19 October 2021 - Akero Therapeutics today announced that the U.S. FDA has granted fast track designation to its lead program ...
Posted by Michael Wonder on 12 Oct 2021
GenSight Biologics announces FDA grant of fast track designation for optogenetic therapy GS030 as treatment for retinitis pigmentosa
12 October 2021 - GenSight Biologics today announced that the U.S. FDA has granted fast track designation to GS030, which combines ...
Posted by Michael Wonder on 09 Oct 2021
Egetis Therapeutics receives FDA fast track designation for Emcitate for MCT8 deficiency
8 October 2021 - Egetis Therapeutics today announced that the U.S. FDA has granted the company’s lead candidate drug Emcitate, currently ...
Posted by Michael Wonder on 08 Oct 2021
Recursion is granted FDA fast track designation for REC-2282 for the potential treatment of NF2 mutated meningiomas
7 October 2021 - Recursion today announced that the U.S. FDA has granted the company fast track designation for the ...