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Crinetics
NEWS

Crinetics Pharmaceuticals Doses First Patient in P-II/III (BALANCE-CAH) Trial of Atumelnant for Pediatric Congenital Adrenal Hyperplasia

Shots: Crinetics has dosed the first patient with atumelnant in the P-II/III (BALANCE-CAH) trial for the treatment of classic congenital adrenal hyperplasia (CAH) in children & adolescents The study will evaluate atumelnant across 3 phases: a P-II semi-sequential dose-ranging Part A, followed by a P-III PBO-controlled Part B, & an OLE portion in Part C…
3 days ago

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BPGbio’s BPM31510 Receives the US FDA Orphan Drug Designation to Treat Primary CoQ10 Deficiency

Shots: The US FDA has granted ODD to BPM31510, for the treatment of primary coenzyme Q10 (CoQ10) deficiency (PCQD) Designation was supported by insights from BPGbio’s NAi Interrogative Biology platform, which leverages Bayesian AI to analyze & map thousands of human biological data points, validating BPM31510’s therapeutic potential BPM31510 is designed for IV administration of CoQ10 directly…
3 days ago

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Mabwell Doses First US Patient in P-I/II Trial of 7MW4911 for Gastrointestinal (GI) Cancers

Shots: Mabwell has dosed the first patient with 7MW4911 in a P- I/II study in the US for the treatment of advanced colorectal cancer & other advanced GI tumors Preclinical studies showed that 7MW4911 delivered potent antitumor activity across CDX/PDX GI tumor models & outperformed MMAE/DXd-based ADCs in multidrug-resistant settings. It also reversed tumor progression after…
3 days ago

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Guardant Health Secures the US FDA Approval for Guardant360 CDx as a Companion Diagnostic for Pfizer’s Braftovi

Shots: The US FDA has approved Guardant360 CDx as a companion diagnostic to identify pts with BRAF V600E-mutant metastatic colorectal cancer who may benefit from treatment with Pfizer’s Braftovi (encorafenib) + cetuximab & CT Accelerated approval was backed by P-III (BREAKWATER) trial assessing encorafenib + cetuximab & CT vs SoC, in which Guardant360 CDx, a non-invasive genomic…
3 days ago

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Janux Therapeutics and BMS Forge ~$850M Deal to Develop Therapies in Oncology

Shots: Janux has entered into a collaboration & exclusive global license agreement with BMS to develop a novel, undisclosed tumor-activated therapy targeting a validated solid-tumor antigen expressed across multiple cancer types Janux will advance the program through preclinical development & IND submission, after which BMS will hold the IND, lead global development & commercialization, with…
3 days ago

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NEWS

IntraBio Reports Topline P-III (IB1001-303) Trial Data on Aqneursa for Ataxia-Telangiectasia

Shots: IntraBio has reported the topline P-III (IB1001-303) trial data on Aqneursa (levacetylleucine) vs PBO in pediatric & adult pts with Ataxia-Telangiectasia (A-T) Trial met the 1EP with a significant –1.88 SARA improvement vs PBO (–1.92 vs –0.14) after 12wks.& achieved 2EPs, showing meaningful gains on ICARS (–4.22 vs –1.69) & CGI-I (–0.6 vs –0.2)…
4 days ago

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CereVasc Completes Patient Enrolment in ETCHES 1 Study of eShunt System for Communicating Hydrocephalus

Shots: CereVasc completed enrollment in the ETCHES-1 Study evaluating its eShunt System in adults with communicating hydrocephalus resulting from elevated intracranial pressure following post-aneurysmal subarachnoid hemorrhage Study will assess changes in intracranial pressure, device performance & safety, with pts monitored for safety outcomes for up to 24mos. following the procedure eShunt System is designed to…
4 days ago

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Celcuity
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The US FDA Accepts Celcuity’s Gedatolisib NDA under Priority Review to Treat HR+/HER2- Breast Cancer

Shots: The US FDA has accepted NDA under priority review of gedatolisib in HR+/ HER2-, PIK3CA wild-type advanced breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jul 17, 2026) NDA was supported by data from the PIK3CA wild-type cohort of the P-III (VIKTORIA-1) study assessing gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2-…
4 days ago

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NEWS

Trisol Medical Reports US Early Feasibility Study Results on Transcatheter Tricuspid Valve Replacement (TTVR) System

Shots: The US Early Feasibility Study assessed TTVR system in 22 pts with severe to torrential tricuspid regurgitation; enrollment in the trans-jugular cohort is complete, with the study continuing via Trisol’s newly developed trans-femoral access route Safety outcomes showed <5% permanent pacemaker need at 30 days, with considerable reduction in tricuspid regurgitation following implantation At 30 days…
4 days ago

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