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RSS FeedPosted 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 ...
Posted by Michael Wonder on 26 Jul 2022
Ionis announces that FDA accepts new drug application and grants priority review of tofersen for a rare, genetic form of ALS
26 July 2022 - 12 month data included in the filing show that earlier initiation of tofersen slowed decline across measures ...
Posted by Michael Wonder on 26 Jul 2022
ERC granted FDA fast track designation for sitoiganap in patients with recurrent glioblastoma
26 July 2022 - ERC Belgium today announced that the U.S. FDA has granted fast track designation to Sitoiganap (Gliovac or ...
Posted by Michael Wonder on 22 Jul 2022
Daewoong Pharmaceutical gets first Korean US FDA fast track for new idiopathic pulmonary fibrosis drug
20 July 2022 - First-in-class new drug to quickly take on the pulmonary fibrosis market, predicted to reach $6.1 billion ...
Posted by Michael Wonder on 21 Jul 2022
Olema Oncology receives FDA fast track designation for OP-1250 for the treatment of ER positive, HER2 negative metastatic breast cancer
21 July 2022 - Olema Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to OP-1250, the ...