Elevation Spine Receives FDA Clearance for Saber-XA ALIF System

Shots: The US FDA has granted 510(k) clearance to Saber-XA, an anterior lumbar interbody fusion (ALIF) system combining an expandable cage with a zero-profile anterior lumbar plate, enabling intra-operative customization of implant height & lordosis Saber-XA allows surgeons to independently adjust implant height & lordotic angle based on patient anatomy, with multiple configurations across its…

ByRidhi RastogiAugust 12, 2026

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Rhythm Pharmaceuticals’ Imcivree Receives Expanded UK Authorization for Hypothalamic Obesity

Shots: The MHRA has expanded market authorization for Imcivree (setmelanotide) to incl. the treatment of obesity & control of hunger in pts (≥4yrs.) with acquired hypothalamic obesity due to hypothalamic injury or impairment Approval was backed by the global P-II/III (TRANSCEND) trial assessing Imcivree vs PBO in 120 pts with acquired HO, meeting its 1EP with…

ByRidhi RastogiAugust 12, 2026

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Belenos Biosciences Reports P-II Trial Results on BEL512 for CRSwNP

Shots: P-II trial, conducted by Belenos’partner Keymed Biosciences, assessed BEL512 (SC; 300mg, Q12W/Q24W or 600mg, Q24W) vs PBO, both on top of intranasal corticosteroid (QD), in 120 Chinese pts with CRSwNP with NPS of ≥5 (≥2 polyps/nostril) & a NCS of 2-3 Trial met its 1 & 2EPs, with the BEL512 showing statistically significant improvements…

ByRidhi RastogiAugust 12, 2026

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Belite Bio Receives the US FDA Priority Review for Tinlarebant to Treat Stargardt Disease Type 1

Shots: The US FDA has accepted & granted Priority Review to the NDA for tinlarebant for the treatment of Stargardt Disease Type 1 (STGD1), with a PDUFA target date of Feb 12, 2027 NDA was supported by the P-III (DRAGON) trial assessing tinlarebant vs PBO in STGD1 pts, showing 35.7% reduction in atrophic retinal lesion growth…

ByRidhi RastogiAugust 12, 2026

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Mereo BioPharma and Sentynl Therapeutics Ink ~$475M Pact for Alvelestat

Shots: Sentynl, a subsidiary of Zydus, has entered into an option & license agreement with Mereo for the US commercial & global manufacturing rights to alvelestat for Alpha-1 Antitrypsin Deficiency-Associated Lung Disease (AATD-LD) Sentynl will have an exclusive option to license alvelestat in the US, while Mereo retains ex-US commercial rights; Sentynl will also hold…

ByRidhi RastogiAugust 12, 2026

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Bracco Imaging Secures FDA and Health Canada Clearances for VueJect

Shots: Bracco Imaging has received the US FDA 510(k) clearance & Health Canada authorization for VueJect, its dedicated ultrasound contrast delivery system designed specifically for cardiology imaging VueJect is designed to improve workflow efficiency, reduce operator variability & enable continuous administration of ultrasound contrast agents for more consistent enhancement during cardiac imaging VueJect will initially…

ByRidhi RastogiAugust 12, 2026

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Alfasigma to Acquire Nordic Pharma, Expanding Rheumatology and Global Reach

Shots: Alfasigma has entered into an agreement with SEVER Life Sciences to acquire 100% of Nordic Pharma & its subsidiaries, adding the Nordimet methotrexate franchise to Alfasigma’s rheumatology portfolio alongside Jyseleca Deal will expand Alfasigma’s commercial footprint through Nordic Pharma’s direct operations across 18 EU countries, while adding platforms in Canada & Japan. The portfolio…

ByRidhi RastogiAugust 11, 2026

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Ceribell Secures FDA Clearance for AI-Powered EEG Enhancements

Shots: The US FDA has granted 510(k) clearance to two AI algorithm enhancements, Epileptiform Abnormality Detection & Artifact Reduction, which are integrated into its cloud-based Neurology Portal The Artifact Reduction algorithm identifies interference from patient movement, medical equipment, and physiological signals, while Epileptiform Abnormality Detection flags abnormal patterns across lengthy EEG recordings, helping neurologists navigate…

ByRidhi RastogiAugust 11, 2026

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Revvity Debuts SuperFlex Prenatal Screening System

Shots: Revvity has launched SuperFlex, a compact immunoassay platform for rapid, reliable prenatal screening in lower-volume laboratories & clinics, incl. preeclampsia testing SuperFlex offers an affordable, low-waste setup with annual maintenance, simplified operation and minimal training, plus flexible throughput with continuous loading and results in as little as 14min SuperFlex supports first & second-trimester biochemical…

ByRidhi RastogiAugust 11, 2026

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Silence Therapeutics Reports Topline P-II (SANRECO) Trial Results of Divesiran in Polycythemia Vera

Shots: Silence has reported topline P-II (SANRECO) trial results assessing divesiran (6mg/kg, SC, Q6W or Q12W) vs PBO in 48 phlebotomy-dependent patients with polycythemia vera (PV); P-III PV trial for Q12W dosing to initiate in H1’27 Trial met its 1EP, with significantly more PV pts responding to divesiran vs PBO (88% vs 19%). Response was…

ByRidhi RastogiAugust 11, 2026

Ridhi Rastogi

Elevation Spine Receives FDA Clearance for Saber-XA ALIF System

Rhythm Pharmaceuticals’ Imcivree Receives Expanded UK Authorization for Hypothalamic Obesity

Belenos Biosciences Reports P-II Trial Results on BEL512 for CRSwNP

Belite Bio Receives the US FDA Priority Review for Tinlarebant to Treat Stargardt Disease Type 1

Mereo BioPharma and Sentynl Therapeutics Ink ~$475M Pact for Alvelestat

Bracco Imaging Secures FDA and Health Canada Clearances for VueJect

Alfasigma to Acquire Nordic Pharma, Expanding Rheumatology and Global Reach

Ceribell Secures FDA Clearance for AI-Powered EEG Enhancements

Revvity Debuts SuperFlex Prenatal Screening System

Silence Therapeutics Reports Topline P-II (SANRECO) Trial Results of Divesiran in Polycythemia Vera

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