FDA grants ODD status to Zai Lab’s lung cancer treatment
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Zai Lab’s delta-like ligand 3 (DLL3) antibody-drug conjugate (ADC), ZL-1310, for small cell lung cancer (SCLC).
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FDA Grants Orphan & Rare Pediatric Designations to Tikun’s FD Treatments
The goal is to treat familial dysautonomia patients with a single injection.
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FDA grants fast track designation to N-acetylcysteine amide tablets from Nacuity Pharmaceuticals
The NPI-001 (N-acetylcysteine amide) tablets are a proprietary investigational therapy for the treatment of patients with ...
Zai Lab Gets FDA Orphan Drug Designation For ZL-1310 To Treat Small Cell Lung Cancer
Zai Lab Limited (ZLAB) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation or ODD to ZL-1310, a ...
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Zai Lab Receives Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the Treatment of Small Cell Lung Cancer (SCLC)
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class ...
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Insilico Medicine doses first patient in Phase I Trial of ISM6331 for mesothelioma
Insilico Medcine( "Insilico") , a clinical stage generative artificial intelligence (AI)-driven biotechnology company today announced the first patient has been dosed in the global multicenter Phase I ...
Nuvalent: A First Look
Nuvalent, Inc. shares have fallen approximately 30% after promising updates on its two lead NSCLC candidates rallied the ...
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FDA breakthrough status for Bluejay’s CHD therapy brelovitug
Breakthrough therapy designation recognises the potential of brelovitug to transform the lives of people living with CHD. We ...
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FDA grants fast-track designation to myotonic dystrophy type 1 treatment
The FDA has granted fast-track designation to an investigational antisense oligonucleotide to treat individuals with myotonic ...
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Zydus Strides Forward with Orphan Drug for ALS
Zydus Lifesciences announced that Usnoflast, a treatment for amyotrophic lateral sclerosis (ALS), has received Orphan Drug Designation from the US FDA. This designation supports the development of ...
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What is an Orphan Drug? A Guide to Rare Disease Therapies
Orphan drugs offer critical treatment options for rare diseases, improving quality of life for underserved patients and ...
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Bluejay Therapeutics’ brelovitug secures FDA breakthrough status for chronic HDV
The FDA has granted breakthrough therapy designation to Bluejay Therapeutics’ brelovitug for the treatment of chronic hepatitis delta, for which no approved therapies currently exist in the U.S., the ...