Kuickresearch::Industry News

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VectivBio Earns FDA Orphan Drug Designation for Apraglutide

Release Date: 07 September 2021

US FDA has allowed orphan drug designation to apraglutide, a next-generation, long-acting GLP-2 analog being developed for rare gastrointestinal (GI) diseases, for the prevention of acute graft-versus-host disease (aGVHD). Gastrointestin...

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CPI-613® (Devimistat) Receives Orphan Drug Designation From U.S FDA

Release Date: 06 September 2021

US FDA grants Orphan Drug Designation to CPI-613andreg; (devimistat) for the treatment of biliary cancer. The EMA has granted orphan drug designation to devimistat for acute myeloid leukemia and pancreatic cancer. Biliary cancer that inc...

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Atsena Therapeutics Earns Orphan Drug Designation from US FDA for Novel Gene Therapy

Release Date: 06 September 2021

US FDA has granted orphan drug designation for its investigational gene therapy product for the treatment of GUCY2D-associated Leber congenital amaurosis (LCA1), a genetic eye disease that affects the retina. Efficacy and safety of the g...

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US FDA Grants Orphan Drug Designation For Xywav

Release Date: 05 September 2021

US FDA has granted Orphan Drug Designation for Xywavandtrade; (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older wi...

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BNL-101 Wins Orphan Drug Designation To Treat Malignant Gliomas

Release Date: 05 September 2021

Bionaut Labs, a company has been grated the orphan drug designation from FDA to BNL-101 for the treatment of all malignant gliomas including diffuse intrinsic pontine glioma in pediatric and adult patients. BNL-101 is a drug-device combi...

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US FDA Grants Orphan Drug Designation for GS-100 Drug

Release Date: 04 September 2021

Grace Science receives orphan drug designation from FDA for GS-100, an investigational AAV9 gene replacement therapy to treat NGLY1 deficiency. NGLY1 deficiency is an ultra-rare genetic disease caused by loss of function mutations in the...

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EMA Grants Orphan Drug Designation to CLN5 Batten Disease Gene Therapy

Release Date: 04 September 2021

Neurogene Inc., a company receives Orphan Drug Designation from European Medicines Agency (EMA) to its adeno-associated virus (AAV) encoding a codon-optimized human CLN5 transgene (hCLN5) to treat CLN5, a subtype of Batten disease. Sympt...

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EMA Grants Orphan Drug Designation To SLS-005

Release Date: 03 September 2021

Seelos Therapeutics receives orphan drug designation from The European Medicines Agency (EMA) for SLS-005 for the treatment of amyotrophic lateral sclerosis (ALS). In ALS, the accumulation of proteins such as TDP-43 and SOD1 in nerve cel...

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PT001 Receives Orphan Drug Designation To Treat Pulmonary Arterial Hypertension

Release Date: 03 September 2021

PulmoSIM Therapeutics receives Orphan Drug Designation from US FDA for PT001 for the treatment of Pulmonary Arterial Hypertension (PAH). PAH is a disturbing, progressive and life-threatening disorder characterized by increased pressure i...

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FDA Approve Peptide Drug Conjugate Antibody To Witness Positive Outlook In Future

Release Date: 17 April 2021

Global Peptide Drug Conjugate Market and Clinical Trials Insight 2026 Report Highlights:

 

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