Shots:
Schrödinger has entered into a strategic agreement with BMS to deploy Bunsen, its agentic AI co-scientist, across BMS's research organization, expanding the companies' long-standing partnership
As per the deal, Schrödinger will work with BMS to develop new Bunsen capabilities alongside its computational technologies for large-scale chemical exploration & RetroSynth, its AI-driven synthesis planning platform …
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The US FDA has granted 510(k) clearance to Revi Extend, the next-generation implant for Revi System to treat urgency urinary incontinence (UUI), with the new implant offering an extended lifespan of 15yrs.Limited US launch planned for Q4’26
Built on Implantable Tibial Neuromodulation (ITNM), Revi System is designed to reduce the long-term treatment burden through…
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The US FDA has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. DEA scheduling decision is expected within 90 days, after which it will be available through a specialty pharmacy
Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in…
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Summit has initiated P-II/III (HARMONi-GU1) trial of ivonescimab + enfortumab vedotin (EV) against Keytruda + EV as first-line treatment of locally advanced or metastatic urothelial (bladder) cancer
The global, multi-regional trial will enroll ~800 pts through P-III, with site activations beginning later this year. P-II will determine the recommended P-III dose of ivonescimab in…
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Natera has submitted an application to Japan's PMDA seeking approval of Signatera as a companion diagnostic (CDx) for muscle-invasive bladder cancer (MIBC)
The submission expands the company's presence in Japan, where Signatera became the country's first PMDA-approved molecular residual disease (MRD) test for colorectal cancer in Jun 2026
Application is supported by data from…
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The US FDA has accepted sBLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked MMP associated with masseter muscle activity in adults
sBLA was supported by 2 P-III (M21-416 and M21-417) studies, both of which met their 1EPs & showed improvements in the severity of MMP vs…
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SOPHiA GENETICS has entered a global collaboration with AstraZeneca to develop, validate, & commercialize two companion diagnostics (CDx) supporting precision oncology therapies
The multi-year collaboration will leverage SOPHiA’s decentralized clinical trial assays & CDx capabilities to advance development & commercialization of the CDx programs
As per the deal, SOPHiA GENETICS will develop its Solid Tumor…
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The US FDA has granted 510(k) clearance to the OMNI Ultra Surgical System for canaloplasty followed by trabeculotomy for the reduction of intraocular pressure (IOP) in adults with primary open-angle glaucoma (POAG)
The OMNI platform is backed by extensive clinical evidence showing sustained IOP reduction and reduced medication use, with the OMNI Ultra remaining on…
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Integer and KKR have entered into a definitive agreement under which an affiliate of investment funds managed by KKR will acquire Integer, delisting it from NYSE
As per the deal, KKR will acquire Integer in an all-cash transaction valued at $127 per share, representing the total enterprise value of ~$5.7B
As a KKR portfolio…
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Galaxy has received CE Mark under the EU MDR 2017/745 for its SEAL Embolization System, following assessment by Notified Body DQS Medizinprodukte. Launch expected across selected EU markets, with FDA’s PMA application underway
The SEAL Embolization System is an intrasaccular device for endovascular treatment of ruptured & unruptured wide-neck intracranial aneurysms, supporting aneurysm sizes…

