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RSS FeedPosted by Michael Wonder on 14 Sep 2022
TRACON Pharmaceuticals announces fast track designation by the FDA for envafolimab for the treatment of the soft tissue sarcoma subtypes of UPS and MFS
14 September 2022 - TRACON Pharmaceuticals announced today that the US FDA has granted fast track designation for the development of ...
Posted by Michael Wonder on 14 Sep 2022
aTyr Pharma receives FDA fast track designation for efzofitimod for treatment of systemic sclerosis-associated interstitial lung disease
13 September 2022 - Second fast track designation for efzofitimod clinical program. ...
Posted by Michael Wonder on 13 Sep 2022
Anthos Therapeutics announces that abelacimab has received FDA fast track designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation
8 September 2022 - This is the second fast track designation issued by the FDA for abelacimab. ...
Posted by Michael Wonder on 12 Sep 2022
Mersana Therapeutics announces FDA fast track designation granted to XMT-1660 for the treatment of triple negative breast cancer
12 September 2022 - XMT-1660 currently being studied in a Phase 1 trial enrolling patients with breast, endometrial and ovarian cancers. ...
Posted by Michael Wonder on 08 Sep 2022
Silence Therapeutics announces FDA fast track designation for SLN124, a novel investigational siRNA therapy for the treatment of polycythemia vera
8 September 2022 - Designation provides potential for expedited drug development path. ...
Posted by Michael Wonder on 07 Sep 2022
AmMax Bio announces AMB-05X granted FDA fast track designation for the treatment of tenosynovial giant cell tumour
7 September 2022 - Proof of concept established in Phase 2 Trial of TGCT, with positive efficacy results across multiple clinical ...
Posted by Michael Wonder on 31 Aug 2022
US FDA grants fast track designation for Longeveron’s Lomecel-B product for treatment of hypoplastic left heart syndrome in infants
31 August 2022 - New designation may expedite FDA review and potential approval to address this life-threatening heart condition affecting ...
Posted by Michael Wonder on 31 Aug 2022
Scilex announces that the FDA has granted fast track designation for SP-103 (lignocaine 5.4% topical system), next generation triple strength formulation of ZTlido for the treatment of acute low back pain
30 August 2022 - According to the CDC in 2020, low back pain was the most common type of pain reported ...
Posted by Michael Wonder on 23 Aug 2022
Synlogic granted FDA fast track designation for SYNB1353 for the treatment of homocystinuria
23 August 2022 - Synlogic today announced that the U.S. FDA has granted fast track designation to SYNB1353 for the potential ...
Posted by Michael Wonder on 23 Aug 2022
Merck receives fast track designation from the US FDA for MK-2060, an investigational anti-coagulant therapy
23 August 2022 - Phase 2 study of MK-2060 currently on-going in people with end stage renal disease receiving haemodialysis. ...
Posted by Michael Wonder on 11 Aug 2022
aTyr Pharma receives FDA fast track designation for efzofitimod (ATYR1923) for treatment of pulmonary sarcoidosis
11 August 2022 - Company is investigating efzofitimod in global pivotal Phase 3 EFZO-FIT study in pulmonary sarcoidosis patients. ...
Posted by Michael Wonder on 09 Aug 2022
Relmada Therapeutics receives FDA fast track designation for REL-1017 as a monotherapy for the treatment of major depressive disorder
9 August 2022 - Relmada Therapeutics today announced that the U.S. FDA has granted fast track designation to REL-1017, the Company's ...
Posted by Michael Wonder on 04 Aug 2022
Vaxcyte provides positive regulatory updates for VAX-24 adult and paediatric programs
4 August 2022 - Company receives FDA fast track designation for VAX-24 in adults. ...
Posted by Michael Wonder on 03 Aug 2022
AnHeart Therapeutics receives FDA breakthrough therapy designation for taletrectinib in ROS1 positive non-small-cell lung cancer
3 August 2022 - FDA breakthrough designation reinforces significant unmet need in the treatment of this highly aggressive cancer. ...
Posted by Michael Wonder on 01 Aug 2022
ALX Oncology’s evorpacept receives fast track designation from FDA as first-line treatment for head and neck squamous cell carcinoma
1 August 2022 - ALX Oncology today announced that the U.S. FDA has granted fast track designation to evorpacept, a next ...