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Systematic, data-driven science coverage · Saturday, September 5, 2026
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Regulatory & Policy

FDA approves Rocket Pharmaceuticals' gene therapy Kresladi for severe pediatric leukocyte adhesion deficiency-I

The US FDA has granted accelerated approval to KRESLADI (marnetegragene autotemcel), an autologous hematopoietic stem cell-based gene therapy developed by...

Mar 30
Regulatory & Policy

FDA approves Corcept Therapeutics' Lifyorli for platinum-resistant ovarian cancer

The US FDA on March 25, 2026, approved Lifyorli (relacorilant) in combination with nab-paclitaxel for the treatment of adults with platinum-resistant...

Mar 30
Regulatory & Policy

FDA approves Denali Therapeutics' Avlayah for neurologic symptoms of Hunter syndrome in pediatric patients

The US FDA has granted accelerated approval to AVLAYAH (tividenofusp alfa-eknm), an enzyme replacement therapy developed by Denali Therapeutics for the...

Mar 30
Development

EpiBiologics Launches Phase 1 Trial of EPI-326 EGFR-Degrading Bispecific Antibody in NSCLC and HNSCC

EpiBiologics has posted a Phase 1 clinical trial (NCT07462377) for EPI-326, a tissue-selective bispecific antibody targeting EGFR in patients with locally...

Mar 30
Development

Kymera Therapeutics Advances KT-579 IRF5 Degrader Into Phase 1 Trial for Autoimmune Disease

Kymera Therapeutics has begun dosing participants in the first-ever clinical study of a drug designed to destroy interferon regulatory factor 5, a...

Mar 30
Business

Unnatural Products and Novartis sign USD 1.8b macrocyclic peptide deal for cardiovascular disease

Unnatural Products, Inc. (UNP), a privately held biotechnology company headquartered in Santa Cruz, California, announced a research collaboration and...

Mar 31
Development

Pilatus Biosciences doses first patient with anti-CD36 antibody PLT012 in advanced solid tumors

Pilatus Biosciences has dosed the first patient in a Phase 1 clinical trial of PLT012, a humanized monoclonal antibody that blocks CD36-mediated fatty acid...

Mar 31
Development

Edding Genor's EDP167 Enters Phase II Trial in Growing Race to Silence ANGPTL3

Edding Genor Group Holdings Limited, the Hong Kong-listed specialty pharmaceutical company, has completed a first-in-human Phase I study of EDP167, a...

Mar 30
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Development

Mirador Therapeutics Launches Phase 1 Trial of MT-251 Bispecific Antibody Targeting TL1A and IL-23

Mirador Therapeutics has initiated dosing in a Phase 1 MT-251 clinical trial evaluating the safety, tolerability, pharmacokinetics, and immunogenicity of...

Mar 30
Development

Structure Therapeutics' aleniglipron achieves 16.3% weight loss in phase 2 obesity trial

Structure Therapeutics (NASDAQ: GPCR), a San Francisco-based clinical-stage biopharmaceutical company, reported topline data from its Phase 2 ACCESS II...

Mar 31
Business

Vanda Pharmaceuticals' imsidolimab BLA accepted by FDA for generalized pustular psoriasis treatment

Washington, D.C.-based Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced on February 25, 2026, that the US FDA has accepted its Biologics License...

Mar 31
Development

Ascletis reports positive phase II data for ASC30 depot formulation in obesity treatment

Hong Kong-based Ascletis Pharma Inc. announced topline results from a US Phase II study of ASC30, a small molecule GLP-1 receptor agonist formulated as a...

Mar 31
Regulatory & Policy

China's NMPA approves Xdemvy for Demodex blepharitis, triggering $15M milestone payment to Tarsus

China's National Medical Products Administration has approved XDEMVY (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis, making...

Mar 30
Development

Inhibikase's IB-001: First-in-Human Phase 1 Trial Targets Chronic Hepatitis B Treatment

A Novel Approach to Chronic Hepatitis B: Inside Inhibikase's First-in-Human IB-001 Trial

Mar 30
Regulatory & Policy

AnnJi Pharmaceutical's AJ201 Secures US FDA Fast Track Designation for Kennedy's Disease Treatment

FDA Grants Fast Track Designation to Promising Kennedy's Disease Treatment

Mar 30