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FDA fast tracks Quince Therapeutics’ rare ataxia drug EryDex
Pharmaceutical Technology via Yahoo Finance· 6 days agoCalifornia-based biotech Quince Therapeutics has won fast track designation from the US Food and ...
Adicet Bio gains on FDA fast track designation for ADI-001 in lupus nephritis
Seeking Alpha· 5 days agoAdicet Bio (ACET) on Wednesday said that the U.S. Food and Drug Administration has granted Fast ...
Repare (RPTX) Up 14% as Ovarian Cancer Combo Gets Fast Track Tag
Zacks via Yahoo Finance· 4 days agoRepare (RPTX) rises 14% as the FDA grants Fast Track designation to its investigational...
Theriva Biologics Receives Fast Track Designation From FDA For VCN-01 For Treating Metastatic...
Benzinga· 4 days agoThe company recently achieved a significant milestone as the U.S. FDA granted Fast Track Designation...
Adicet Bio gains FDA Fast Track for lupus nephritis treatment By Investing.com
Investing.com· 5 days ago(NASDAQ: ACET), a biotechnology firm in the clinical stage, announced today that the U.S. Food and ...
FDA accepts filing of Leqembi® (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of...
Benzinga· 5 hours agoBioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that that the U.S. Food and Drug Administration (FDA) has accepted Eisai's ...
BAI, FDA in tieup to accelerate vaccine testing - BusinessWorld Online
BusinessWorld· 6 days agoTHE Bureau of Animal Industry (BAI) and the Food and Drug Administration (FDA) signed a memorandum...
The FDA may approve psychedelics for treating PTSD. Here's what to know
Quartz· 7 days agoThe public benefit company Lykos Therapeutics submitted a new drug application late last year to the...
FDA Accepts Eisai’s Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application...
Morningstar· 9 hours agoTOKYO and CAMBRIDGE, Mass., June 09, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”)
Moderna's MMA candidate nabs spot in FDA pilot for rare disease drugs
FierceBiotech· 3 days agoModerna’s methylmalonic acidemia candidate, mRNA-3705, will be developed under the FDA’s START pilot...