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RSS FeedPosted by Michael Wonder on 08 Jun 2021
BerGenBio receives FDA fast track designation for bemcentinib/anti-PD-(L)1 combination in NSCLC
8 June 2021 - First recognition by a regulator of AXL positive patients as a target population. ...
Posted by Michael Wonder on 02 Jun 2021
Boehringer Ingelheim and Zealand Pharma receive FDA fast track designation for investigational treatment for NASH
2 June 2021 - FDA’s fast track designation for the GLP-1/glucagon dual agonist underscores the urgent need for new treatment options ...
Posted by Michael Wonder on 01 Jun 2021
BridgeBio Pharma receives FDA fast track designation for encaleret for the treatment of autosomal dominant hypocalcaemia type 1
1 June 2021 - BridgeBio Pharma today announced that the U.S. FDA granted fast track designation for encaleret for the treatment ...
Posted by Michael Wonder on 28 May 2021
Novartis receives FDA fast track designation for sabatolimab (MBG453) in myelodysplastic syndromes
25 May 2021 - Novartis today announced that the US FDA has granted fast track designation for sabatolimab (MBG453) for the ...
Posted by Michael Wonder on 26 May 2021
Illuminare-1, a novel nerve visualisation investigational fluorophore, granted fast track designation by U.S. FDA
25 May 2021 - Illuminare Biotechnologies announced that its novel nerve imaging agent, Illuminare-1, has been granted fast track designation by ...
Posted by Michael Wonder on 25 May 2021
Scholar Rock receives fast track designation from the U.S. FDA for apitegromab for the treatment of patients with spinal muscular atrophy
24 May 2021 - Builds on Priority Medicines (PRIME) designation recently granted by the EMA recognising the unmet medical needs of ...
Posted by Michael Wonder on 17 May 2021
AffyImmune Therapeutics' AIC100 granted fast track designation for treating thyroid cancer
17 May 2021 - AffyImmune Therapeutics announced today that the US FDA granted fast track designation to its lead compound, AIC100, ...
Posted by Michael Wonder on 14 May 2021
BridgeBio Pharma receives FDA fast track designation for investigational gene therapy for congenital adrenal hyperplasia
14 May 2021 - BridgeBio Pharma today announced that the U.S. FDA granted fast track designation to BBP-631, an investigational adeno-associated ...
Posted by Michael Wonder on 13 May 2021
Palisade Bio receives FDA fast track designation for LB1148 for reduction of adhesions following abdominal and pelvic surgery
13 May 2021 - LB1148 was previously granted fast track designation from the U.S. FDA for the treatment of post-operative GI ...
Posted by Michael Wonder on 13 May 2021
Fulcrum Therapeutics announces U.S. FDA grants fast track designation to losmapimod for the potential treatment of facioscapulohumeral muscular dystrophy
12 May 2021 - Fulcrum Therapeutics today announced that the U.S. FDA has granted fast track designation to losmapimod for ...
Posted by Michael Wonder on 12 May 2021
Evofem Biosciences receives fast track designation for EVO100 for prevention of gonorrhoea in women
12 May 2021 - Potential for expedited NDA review of EVO100 by FDA. ...
Posted by Michael Wonder on 12 May 2021
Alume Biosciences granted FDA fast track designation of ALM-488 for surgical nerve visualisation
12 May 2021 - Fast track designation highlights the urgent need for improved intra-operative nerve identification. ...
Posted by Michael Wonder on 11 May 2021
FDA grants fast track designation to CERC-002 for treatment of hospitalised patients with COVID-19
11 May 2021 - Cerecor today announced that the U.S. FDA has granted fast track designation to CERC-002 for treatment of ...
Posted by Michael Wonder on 10 May 2021
Smart Immune announces FDA orphan drug status, IND acceptance and fast track designation to commence Phase 1/2 clinical trial of proprietary allogeneic T cell progenitor product SMART 101 (ProTcell) for AML and ALL
10 May 2021 - Phase 1/2 trial to begin by fall 2021 at a top US cancer centre. ...
Posted by Michael Wonder on 03 May 2021
ImmunoMet Therapeutics granted fast track designation by U.S. FDA for IM156 in idiopathic pulmonary fibrosis
3 May 2021 - ImmunoMet Therapeutics today announced that the U.S. FDA has granted fast track designation for its lead compound ...