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The US FDA has granted 510(k) clearance to BlueOcean Global’s Excelsior External Fixation System, a circular external fixation platform designed to support both bone reconstruction and soft tissue management
The system is cleared for commercial distribution in the US and will be rolled out initially through select centers, with broader availability planned in the…
NEWS
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Ascletis Pharma reported that the first participants have been dosed in a US 13-week P-II study of ASC30, an oral small-molecule GLP-1 receptor agonist, for the treatment of type 2 diabetes mellitus, with topline data expected in Q3’26
The study will enroll ~100 pts and evaluate ASC30’s effects on HbA1c as a 1EP, and…
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Milestone Pharma has reported Cardamyst (Etripamil) is now available in the US for paroxysmal supraventricular tachycardia (PSVT); national sales force to be deployed in mid-Feb 2026
Cardamyst (Intranasal) is a Bidose (BDS) Liquid Nasal Spray System, a self-administered calcium channel blocker nasal spray for rapid response to PSVT, launching with a patient assistance program…
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MS Pharma has signed a strategic partnership with Hetero to localize five established biosimilars across key areas, including oncology, immunology, and hematology, in the MENA region
The exclusive agreement will be implemented through El Kendi (MS Pharma Group’s Algeria affiliate) and Hetero Biopharma, a subsidiary of Hetero Group
This marks Hetero’s first local partnership in Algeria, supporting…
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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…
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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…
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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…
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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…
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Corcept has reported P-III (ROSELLA) trial data assessing relacorilant (PO, GR antagonist) + nab-paclitaxel vs nab-paclitaxel in 381 pts with PROC
Trial met its 1EP of OS, showing a 35% reduction in death risk (mOS: 16 vs 11.9mos.), & previously met its PFS endpoint with a 30% reduction in progression risk, as presented at…
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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…

