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 Rastogi7 hours ago

NEWS

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 Rastogi11 hours ago

NEWS

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 Rastogi14 hours ago

INSIGHTS+

The US FDA New Drug Approvals in July 2026

Shots: The US FDA approved six notable therapies in July 2026 across nephrology, oncology, cardiometabolic disease, ophthalmology, and neuropsychiatry, highlighting continued progress in specialty and chronic disease treatment. Key approvals included Trutakna (atacicept) for IgA nephropathy, Revtorpyk (gedatolisib) for HR+/HER2- breast cancer, Lipfendra (enlicitide) for hypercholesterolemia, Jideytro (zidesamtinib) for ROS1-positive NSCLC, Lytenava (bevacizumab-vikg) for wet AMD, and Simtriyo (centanafadine) for ADHD, expanding treatment options across diverse patient…

ByDipanshu Dixit1 day ago

NEWS

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 Rastogi1 day ago

NEWS

QIAGEN Reports the US FDA Clearance of QIAstat-Dx BCID GPF Plus AMR Panel for Bloodstream Infection Syndromic Testing

Shots: The US FDA has granted clearance to QIAstat-Dx BCID GPF Plus AMR Panel for bloodstream infection testing The panel identifies 20 gram-positive bacterial & fungal pathogen targets & 10 antimicrobial resistance markers, delivering results in ~1 hour to support rapid clinical decision-making & antimicrobial stewardship Clearance supports QIAGEN’s expansion of its US bloodstream infection…

ByRidhi Rastogi2 days ago

NEWS

Elanco’s CLiK Extra Secures US FDA EUA for New World Screwworm (NWS) Prevention

Shots: FDA has granted Emergency Use Authorization for CLiK Extra (dicyclanil topical suspension) wound spray to prevent NWS infestations in livestock & select captive and wild animal species The spray can be applied around wounds, including those caused by birth or surgery, in sheep, cattle, goats, swine, camelids and several cervid and bison species. It…

ByRidhi Rastogi3 days ago

NEWS

US FDA Accepts sBLA for Merck’s Enflonsia to Expand RSV LRTD Prevention Indication

Shots: FDA has accepted the sBLA of Enflonsia to prevent RSV lower respiratory tract disease (LRTD) in children (<2yrs.) at increased risk for severe RSV disease through their second RSV season (PDUFA: Mar 22, 2027); application is also under EMA review Submissions were supported by P-III (SMART/MK-1654-007) trial assessing Enflonsia in infants & children over…

ByRidhi RastogiAugust 7, 2026

NEWS

Co-Diagnostics Submits FDA 510(k) and CLIA Waiver Applications for Point-of-Care PCR Flu A/B & RSV Test

Shots: Co-Diagnostics submitted a Dual FDA 510(k) premarket notification with a concurrent CLIA Waiver application for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro platform Submission was backed by clinical & analytical performance studies, incl. study of over 1,400 symptomatic pts across 9 US sites, & 27…

ByRidhi RastogiAugust 7, 2026

NEWS

FDA Grants Accelerated Approval to Replimune’s Tudriqev + Opdivo for Unresectable Cutaneous Melanoma Progressed on Anti-PD-1 Based Regimen

Shots: FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg or RP1) + nivolumab for adults with unresectable advanced cutaneous melanoma whose disease progressed on an anti-PD-1 antibody-based regimen P-II (IGNYTE) trial enrolled 140 pts, with 91 efficacy-evaluable pts having ≥1 non-injected lesion. Tudriqev + nivolumab achieved a 24.2% ORR & an mDoR of 14.1mos., with results…

ByRidhi RastogiAugust 7, 2026

Elevation Spine Receives FDA Clearance for Saber-XA ALIF System

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

Bracco Imaging Secures FDA and Health Canada Clearances for VueJect

Ceribell Secures FDA Clearance for AI-Powered EEG Enhancements

QIAGEN Reports the US FDA Clearance of QIAstat-Dx BCID GPF Plus AMR Panel for Bloodstream Infection Syndromic Testing

Elanco’s CLiK Extra Secures US FDA EUA for New World Screwworm (NWS) Prevention

US FDA Accepts sBLA for Merck’s Enflonsia to Expand RSV LRTD Prevention Indication

Co-Diagnostics Submits FDA 510(k) and CLIA Waiver Applications for Point-of-Care PCR Flu A/B & RSV Test

FDA Grants Accelerated Approval to Replimune’s Tudriqev + Opdivo for Unresectable Cutaneous Melanoma Progressed on Anti-PD-1 Based Regimen

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