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BioWorld - Monday, April 6, 2026
Home » Topics » FDA, BioWorld Science

FDA, BioWorld Science
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Illustration demonstrating muscle contraction in amyotrophic lateral sclerosis.
Neurology/Psychiatric

Gene therapy ET-101 awarded orphan drug designation for ALS

Nov. 10, 2022
The FDA has awarded orphan drug designation to Eikonoklastes Therapeutics Inc.'s ET-101 program for the treatment of amyotrophic lateral sclerosis (ALS).
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Ear, Nose and Throat

FDA awards rare pediatric disease designation to OTOF-GT for otoferlin gene-mediated hearing loss

Nov. 7, 2022
The FDA has awarded rare pediatric disease...
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Endocrine/Metabolic

FDA clears allogenic cellular therapy Allostem to enter clinic for type 1 diabetes

Nov. 4, 2022
Creative Medical Technology Holdings Inc. has received FDA clearance of its IND application for a clinical trial of Allostem in type 1 diabetes.
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Immuno-oncology

Omega's OTX-2002 awarded US orphan drug designation for HCC

Nov. 3, 2022
The FDA has awarded orphan drug designation to Omega Therapeutics Inc.'s OTX-2002, a first-in-class epigenomic controller engineered to downregulate c-Myc (MYC), for the treatment of hepatocellular carcinoma (HCC).
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Dermatologic

Brexogen receives FDA clearance for phase I trial of exosome-based therapy for atopic dermatitis

Nov. 3, 2022
The FDA has cleared Brexogen Inc. to initiate a phase I trial of BRE-AD01, an exosome-based therapy for atopic dermatitis.
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Endocrine/Metabolic

Eccogene cleared by FDA to begin phase I study of oral GLP-1 receptor agonist

Nov. 3, 2022
Eccogene (Shanghai) Co. Ltd. has received FDA clearance to begin a phase I study of its glucagon-like peptide 1 (GLP-1) receptor agonist ECC-5004 for type 2 diabetes.
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Cancer cells
Immuno-oncology

Turnstone receives IND clearance for phase I trial of TIDAL-01 for solid tumors

Nov. 2, 2022
Turnstone Biologics Corp. has received IND clearance from the FDA for the company's lead selected tumor-infiltrating lymphocyte (TIL) therapy program, TIDAL-01.
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Cancer

Abbisko cleared to enter clinic with FGFR inhibitor ABSK-121 for solid tumors

Nov. 2, 2022
Abbisko Therapeutics Co. Ltd. has received clearance from the FDA to initiate a phase I...
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Immune checkpoint inhibitors illustration of PD-1, CTLA-4 and PD-L1.
Immuno-oncology

FDA approves IND for bifunctional fusion protein SIM-0237

Oct. 28, 2022
Simcere Pharmaceutical Group announced that the FDA has cleared the company’s IND application for SIM-0237 for the treatment of adult patients with advanced solid tumors.
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Infection

Ascletis files IND application for ASC-10 as treatment of monkeypox virus infection

Oct. 27, 2022
Ascletis Pharma Inc. announces that the company has filed an IND application with the FDA for ASC-10, an oral antiviral drug candidate targeting viral polymerase of monkeypox virus.
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