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BioWorld - Saturday, August 1, 2026
Home » Topics » Regulatory, BioWorld Science

Regulatory, BioWorld Science
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Illustration of man with systemic lupus erythematosus showing rash on face and arms
Immune

Create Medicines’ CRT-402 cleared to enter clinic in Australia

July 31, 2026
No Comments
Create Medicines Inc. has received Human Research Ethics Committee (HREC) approval in Australia to initiate a first-in-human study of CRT-402, the company’s lead in vivo CAR T candidate for the treatment of autoimmune diseases.
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Musculoskeletal

DYNE-302 gets IND for facioscapulohumeral muscular dystrophy

July 28, 2026
No Comments
Dyne Therapeutics Inc. has obtained IND clearance from the FDA for DYNE-302 in facioscapulohumeral muscular dystrophy (FSHD), a rare, genetic disease caused by a mutation in the DUX4 gene. Dyne plans to conduct a phase I trial in ambulatory adults with FSHD.
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Antibody-drug conjugate illustration
Immuno-oncology

Kelun-Biotech’s SKB-565 cleared to enter clinic in China

July 27, 2026
No Comments
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. said its IND application was approved in China for SKB-565, its dual-payload antibody-drug conjugate (ADC), for the treatment of advanced solid tumors.
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AI generated image for researcher developing antisense oligonucleotides
Neurology/psychiatric

Camp4 Therapeutics’ lead ASO approved for clinical trials in Australia

July 27, 2026
No Comments
Camp4 Therapeutics Corp. has received clearance to initiate a phase I/II clinical trial of CMP-002, a potential first-in-class therapeutic for SYNGAP1-related disorder.
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Streptococcus pneumoniae in lungs
Immune

Abera seeks clinical trial clearance for AB-01.12

July 23, 2026
No Comments

Abera Bioscience AB has announced, together with clinical partner Radboud University Medical Center, the submission of a clinical trial application in the Netherlands to initiate a phase I trial of its serotype-independent pneumococcal vaccine candidate AB-01.12.


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Blocks displaying microscopes and money bags

Europe voices concerns on changes to US federal grant rules

July 22, 2026
By Nuala Moran
No Comments
Scientists in Europe have added their voices to the many thousands of objections made against proposed changes to the oversight of U.S. federal research grants, under which political appointees and not peer review experts would have the final say on who and what gets funding. The concern is that awarding grants, based on the principle that research proposals must be in keeping with President Donald Trump’s policy priorities, poses a threat to open scientific inquiry and academic freedom, and also will undermine international research collaboration.
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Skin irritation
Dermatologic

Pharmability’s TIR-C gains trial clearance for atopic dermatitis

July 22, 2026
No Comments
Pharmability AB has received authorization from the Swedish Medical Products Agency to initiate a phase Ib trial of TIR-C in atopic dermatitis.
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Illustration of lipids in the bloodstream
Endocrine/metabolic

Fosun cleared to conduct clinical trials with FXR-0906

July 16, 2026
No Comments
Fosun Pharma subsidiary Fosun Pharmaceutical Industrial Development (Shenzhen) Co. Ltd. has received approval from China’s National Medical Products Administration (NMPA) to commence clinical trials for FXR-0906 for the treatment of hypertriglyceridemia.
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Illustration of heart analysis for DNA and drug impacts
Cardiovascular

Atrium’s ATR-1072 gains IND clearance for PRKAG2 syndrome

July 15, 2026
No Comments
Atrium Therapeutics Inc. has obtained IND clearance from the FDA for ATR-1072 for the treatment of protein kinase AMP-activated non-catalytic subunit γ2 (PRKAG2) syndrome.
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DNA illustration
Neurology/psychiatric

Niagen’s NB-4168 designated orphan drug in EU

July 14, 2026
No Comments
Niagen Bioscience Inc.’s proprietary lead small-molecule drug candidate, NB-4168, has been awarded European orphan drug designation and U.S. rare pediatric disease designation for the treatment of ataxia telangiectasia.
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