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Immuno-oncology

Harbour’s bispecific antibody HBM-9027 cleared to enter clinic in US for solid tumors

Jan. 24, 2024

Harbour Biomed Ltd. has obtained FDA clearance of its IND application to initiate a first-in-human...

Neurology/Psychiatric

Vanda receives IND clearance for ASO for Charcot-Marie-Tooth disease type 2S

Jan. 24, 2024

Vanda Pharmaceuticals Inc. has announced FDA approval of its IND application to evaluate VCA...

Neurology/Psychiatric

Juvena’s JUV-161 awarded US orphan drug designation for myotonic dystrophy type 1

Jan. 24, 2024

The FDA has awarded orphan drug designation to Juvena Therapeutics Inc.’s JUV-161, an...

Endocrine/Metabolic

GC Biopharma’s ERT GC-1130A designated orphan drug in EU for MPS IIIA

Jan. 23, 2024

The EMA has awarded orphan drug designation to GC Biopharma Corp.’s intracerebroventricular enzyme replacement therapy (ERT) candidate, GC-1130A, for mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome type A), developed in collaboration with Novel Pharma Inc.

Immuno-oncology

NK Celltech announces US IND clearance for NK cell therapy NK-010

Jan. 23, 2024

NK Celltech Co. Ltd. has announced FDA clearance for a clinical trial of NK-010, a nongenetically modified allogeneic peripheral blood natural killer (NK) cell drug.

Immuno-oncology

Strand’s STX-001 receives IND clearance from FDA to treat solid tumors

Jan. 23, 2024

Strand Therapeutics Inc. has received IND clearance from the FDA to initiate a first-in-human phase I trial of STX-001 as a new approach for the treatment of solid tumors.

Neurology/Psychiatric

Endocannabinoid reuptake inhibitor SYT-510 granted EU IND

Jan. 19, 2024

Synendos Therapeutics AG has received approval from the European Medicines Agency (EMA) to initiate a first-in-human trial of its lead asset, SYT-510, a first-in-class inhibitor that modulates a newly identified drug target in the endocannabinoid system (ECS) to restore healthy brain physiology.

Ear, Nose & Throat

Sensorion's SENS-501 can enter clinic for genetic hearing loss

Jan. 19, 2024

Sensorion SA has received approval in Europe for its clinical trial application (CTA) to initiate a...

Immuno-oncology

ROR1-targeting PBA-0405 cleared to enter phase 0 trial for solid tumors

Jan. 17, 2024

Presage Biosciences Inc. has announced that the FDA has issued a study may proceed notification for testing a pre-GMP drug candidate with the company’s Comparative In Vivo Oncology (CIVO) platform. Owned by Pure Biologics, the drug candidate, PBA-0405, is a ROR1-targeting compound that has been engineered to induce tumor cell killing by cytotoxic immune cells.

Neurology/Psychiatric

Solid Biosciences’ SGT-003 granted orphan drug designation for Duchenne muscular dystrophy

Jan. 17, 2024

Solid Biosciences Inc.’s SGT-003 has been granted orphan drug designation by the FDA. The company’s next-generation Duchenne muscular dystrophy gene therapy candidate was also granted fast track designation last month.

Today's news in brief
BioWorld
BioWorld briefs for Dec. 24, 2025.
Today's news in brief
BioWorld MedTech
BioWorld MedTech briefs for Dec. 24, 2025.
Researchers discover how glioblastoma tumors dodge chemotherapy
BioWorld MedTech
Researchers at the University of Sydney have uncovered a mechanism that may explain why glioblastoma returns after treatment, and the world-first discovery offers...
HIV research is close to a cure but far from ending the pandemic
BioWorld
Advances in antiretroviral therapy (ART) now allow people living with HIV to lead normal lives with undetectable and nontransmissible levels of the virus in their...
Apollo’s APL-4098 shows potent antileukemic effects
BioWorld Science
Apollo Therapeutics Ltd. has developed APL-4098, a small-molecule general control nonderepressible 2 (GCN2) inhibitor for the potential treatment of AML.

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