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RSS FeedPosted 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 ...
Posted by Michael Wonder on 21 Jul 2022
Pliant Therapeutics receives FDA fast track designation for PLN-74809 for the treatment of primary sclerosing cholangitis
21 July 2022 - Pliant Therapeutics announced today that PLN-74809, its oral, dual-selective αvß6/αvß1 integrin inhibitor, has received fast track designation ...
Posted by Michael Wonder on 20 Jul 2022
Karyopharm granted regulatory designations for eltanexor for the treatment of myelodysplastic syndromes
20 July 2022 - FDA fast track designation and European Commission orphan medicinal product designation underscore the significant need for ...
Posted by Michael Wonder on 19 Jul 2022
Wugen receives US FDA fast track and rare paediatric disease designations for WU-CART-007 for the treatment of R/R T-ALL/LBL
19 July 2022 - Wugen, today announced that the U.S. FDA has granted fast track designation and rare paediatric disease ...
Posted by Michael Wonder on 19 Jul 2022
Peptilogics receives FDA fast track designation for PLG0206, an investigational peptide therapeutic in development for the treatment of peri-prosthetic joint infection
19 July 2022 - PLG0206 has the potential to be the first approved therapy specifically indicated for the treatment of peri-prosthetic ...
Posted by Michael Wonder on 19 Jul 2022
Daewoong's idiopathic pulmonary fibrosis drug gets FDA's fast track status
19 July 2022 - Daewoong Pharmaceutical said that the US FDA had granted fast track designation to its idiopathic pulmonary ...
Posted by Michael Wonder on 14 Jul 2022
FDA grants Alpheus Medical orphan drug and fast track designations for novel sonodynamic therapy for brain cancer
13 July 2022 - The company is currently enrolling patients in a multicentre Phase 1 clinical trial for the treatment ...
Posted by Michael Wonder on 11 Jul 2022
Anthos Therapeutics announces that abelacimab has received FDA fast track designation for the treatment of thrombosis associated with cancer
11 July 2022 - Abelacimab is a dual-acting fully human monoclonal antibody targeting both factor XI and Factor XIa with high ...
Posted by Michael Wonder on 06 Jul 2022
InflaRx receives FDA fast track designation for treatment of ulcerative pyoderma gangrenosum
6 July 2022 - Fast track follows recently reported orphan drug designation by both US FDA and EMA ...