Regulatory & Policy
Henlius Bio readies first-in-class EGFR/c-MET bispecific ADC for Phase I in China
Shanghai Henlius Biotech (HKEX: 2696) announced on May 21, 2026 that China's National Medical Products Administration has approved the investigational new...
Henlius advances STEAP1/CD3/ CD28 trispecific T-cell engager to Phase I in prostate cancer
Shanghai Henlius Biotech (HKEX: 2696) has received clearance to initiate a Phase I clinical trial of HLX3902, a trispecific T-cell engager antibody...
Shanghai Henlius puts B7H3 bifunctional fusion protein into Phase I testing for advanced solid tumours
Shanghai Henlius Biotech (HKEX: 2696) dosed the first patient in the HLX316 clinical trial, a Phase I first-in-human study evaluating the B7-H3-targeting...
CHMP backs tumor-agnostic EU use of Enhertu across HER2-positive solid tumors
Daiichi Sankyo and AstraZeneca's Enhertu receives CHMP recommendation for HER2-positive solid tumors in the EU
IntraBio aiming Aqneursa as first ever treatment for ataxia-telangiectasia
IntraBio files for AQNEURSA approval in ataxia-telangiectasia, seeking first-ever treatment for the rare neurological disease
Leads Biolabs pushing PD-L1/4-1BB BsAb opamtistomig into Phase III for extrapulmonary neuroendocrine carcinoma
Nanjing Leads Biolabs (HK: 9887.HK) has received approval from China's National Medical Products Administration to initiate a pivotal Phase III trial of...
FDA accepts Viatris's NDA for MR-107A-02 fast-acting meloxicam for acute pain
Viatris (Nasdaq: VTRS) has submitted a New Drug Application (NDA) to the US FDA for MR-107A-02 (fast-acting meloxicam), an investigational oral...
Chengdu Origen and Vanotech receive FDA clearance for KHN921 gene therapy in hypertrophic cardiomyopathy
Chengdu Origen Biotechnology and Vanotech have received US FDA clearance to proceed with a Phase I/II clinical trial of KHN921, an AAV9-based gene therapy...
BridgeBio files NDA for encaleret in rare calcium disorder with no approved therapy
An NDA submission for a first-in-indication oral therapy positions encaleret as a potential alternative to a standard of care that has remained unchanged...
Actuate Therapeutics' oral GSK-3β inhibitor elraglusib set for first trials in advanced solid tumors
A shift from intravenous to oral administration marks the next phase of Actuate Therapeutics' (Nasdaq: ACTU) elraglusib program, after the Chicago- and Fort...
Kelun-Biotech's PD-1 x VEGF bispecific antibody receives China IND clearance
China's regulatory clearance for SKB118 marks a dual-jurisdiction entry into clinical development for a PD-1 x VEGF bispecific antibody that is already...
Harbour BioMed's HBM7004 bispecific antibody gains IND approval for advanced solid tumors
A gap in the approved solid tumor immunotherapy landscape has widened further with US FDA clearance of an investigational new drug application for HBM7004,...
ArriVent moving MUC16/NaPi2b-targeted ADC into trials against ovarian and endometrial cancers
ArriVent BioPharma (Nasdaq: AVBP), based in Newtown Square, Pennsylvania, announced IND clearance from the US FDA for ARR-002, a dual-target tetravalent...
FDA adds 3 months to review of Eisai's Leqembi Iqlik subcutaneous formulation for early Alzheimer's
The US FDA has extended its review of a supplemental application for Leqembi Iqlik (lecanemab-irmb), pushing the PDUFA date for the subcutaneous...
Nuvation adds data to sNDA for Ibtrozi in ROS1-positive NSCLC
Nuvation Bio submitted a supplemental New Drug Application (sNDA) to the US FDA for Ibtrozi (taletrectinib), its next-generation ROS1 inhibitor, seeking to...
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