Regulatory & Policy
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...
FDA aligns with Pierre Fabre on Ebvallo resubmission path for EBV+ PTLD treatment
Pierre Fabre Pharmaceuticals has announced it has aligned with the US FDA on a potential path forward for resubmission of the Biologics License Application...
Insilico's rentosertib inhalation solution receives China IND clearance for IPF
Insilico Medicine (HKEX: 3696) announced that China's Center for Drug Evaluation (CDE) has cleared an investigational new drug (IND) application for an...
FDA approves Guardant360 CDx companion diagnostic for Arvinas and Pfizer's Veppanu in advanced breast cancer
The US FDA has approved Guardant360 CDx as a companion diagnostic for Veppanu (vepdegestrant), the PROTAC estrogen receptor degrader jointly developed by...
Clene planning NDA filing for CNM-Au8 gold nanocrystal suspension for ALS
Clene Inc. announced plans to file a New Drug Application (NDA) with the US FDA for CNM-Au8, an oral suspension of gold nanocrystals, seeking accelerated...
IDEAYA Biosciences initiates FDA submission for darovasertib plus crizotinib in metastatic uveal melanoma
IDEAYA Biosciences has initiated a New Drug Application (NDA) submission to the US FDA for darovasertib in combination with crizotinib, seeking approval in...
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