MRI2CT Secures FDA Clearance for AI-Powered NextMR Spine Imaging Platform

Shots: The US FDA has granted 510(k) clearance to NextMR, an AI-powered platform that generatesaccurate 3D bone visualization of the lumbar spine & sacrum directly from standarddiagnostic MRI scans NextMR works on MRI sequences acquired on 1.5T & 3T scanners, and generates 3D bone morphology in under 60sec., potentially reducing the need for additional imaging…

ByRidhi RastogiOctober 7, 2026

NEWS

BridgeBio Pharma Reports the US FDA Priority Review of Oral Infigratinib for Children with Achondroplasia

Shots: The US FDA has accepted NDA & granted Priority Review to infigratinib (PO) for the treatment of children with achondroplasia (PDUFA: Feb 4, 2027). BridgeBio is prepared to launch infigratinib upon approval Trial met its 1EP, with infigratinib improving annualized height velocity at Wk. 52 (mean treatment difference: +2.10cm/yr.) & its key 2EP of…

ByRidhi RastogiOctober 7, 2026

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Abbott Receives FDA Approval for New CardioMEMS HF System Patient-Facing Capabilities

Shots: Abbott received US FDA approval for updates to the CardioMEMS HF System, enabling patients in the US to view their pulmonary artery pressure (PAP) readings through the CardioGuide HF App The updated system includes Dynamic Treatment Plan (DTP), allowing care teams to create personalized medication adjustment plans based on changes in PAP and send…

ByPrince GiriOctober 6, 2026

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The US FDA Approves Eli Lilly’s Jaypirca (Pirtobrutinib) for Certain Patients with Previously Untreated CLL/SLL

Shots: The US FDA has approved an additional indication for Jaypirca (pirtobrutinib, 100 & 50mg) for the treatment of adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) with no known 17p deletion Approval was based on the P-III (BRUIN CLL-313) trial data P-III assessing Jaypirca (200mg, PO, QD until disease progression…

ByRidhi RastogiOctober 5, 2026

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BMS Reports US FDA Approval of Camzyos in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The US FDA has approved Camzyos (mavacamten) for the treatment of symptomatic oHCM to improve functional capacity & symptoms in adults & pediatric pts (≥30kg) Approval was based on P-III (SCOUT-HCM) trial data assessing Camzyos (n=23) vs PBO (n=21) in 44 pts (12 to <18yrs.) with symptomatic NYHA class II-III oHCM, which met its 1EP,…

ByRidhi RastogiOctober 1, 2026

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Ceribell Secures FDA Clearance for Quantitative EEG Trending and Amplitude-Integrated EEG Analysis

Shots: The US FDA has granted 510(k) clearance to a new software for the Ceribell System that converts raw EEG information into simplified easy-to-read trends, helping clinicians monitor changes in brain activity The update adds Alpha-Delta Ratio & Relative Alpha trending for detecting early signs of brain distress & reduced blood flow in high-risk pts,…

ByRidhi RastogiOctober 1, 2026

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Roche Secures US FDA Priority Review for Fenebrutinib in both Relapsing and Primary Progressive Multiple Sclerosis

Shots: The US FDA has accepted an NDA & granted priority review to fenebrutinib for RMS & PPMS based on P-III (FENhance 1 & 2) studies & the P-III (FENtrepid) trial, respectively FENhance 1 & 2 showed fenebrutinib reduced relapses and active & chronic brain lesions vs teriflunomide, lowering ARR by 51.1% & 58.5%, respectively,…

ByRidhi RastogiOctober 1, 2026

NEWS

Meitheal Pharmaceuticals Reports US FDA Approval of High-Concentration Formulation of Yusimry (Biosimilar, Humira)

Shots The US FDA has approved a citrate-free, high-concentration formulation for Yusimry as an interchangeable biosimilar to Humira (adalimumab) Yusimry, a TNF blocker, is available in low and high concentration formulations via autoinjector, with the low-concentration formulation also available as a PFS Emerge Bioscience holds the approved BLA for Yusimry, while Meitheal serves as its…

ByRidhi RastogiSeptember 30, 2026

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Teva Reports the US FDA Approval of Degevma (Biosimilar, Xgeva)

Shots: The US FDA has approved Degevma, a biosimilar version of Xgeva (denosumab), following FDA approval of Ponlimsi (biosimilar, Prolia) in Mar 2026, with launch of both biosimilars anticipated in coming mos. Approval was backed by extensive data, incl. analytical & clinical data showing similar efficacy, safety & immunogenicity profile as the reference product Degevma…

ByRidhi RastogiSeptember 29, 2026

NEWS

AbbVie Reports the US FDA Approval of Juvmo (Tavapadon) for Parkinson’s Disease

Shots: FDA approval was based on the P-III (TEMPO) program, which evaluated Juvmo in early PD pts not taking oral levodopa (TEMPO-1 & 2) & as an adjunct to oral levodopa vs PBO + levodopa in PD pts with motor fluctuations (TEMPO-3) At Wk. 26 in TEMPO-1, Juvmo showed MDS-UPDRS Part II scores of −1.6…

ByRidhi RastogiSeptember 29, 2026

MRI2CT Secures FDA Clearance for AI-Powered NextMR Spine Imaging Platform

BridgeBio Pharma Reports the US FDA Priority Review of Oral Infigratinib for Children with Achondroplasia

Abbott Receives FDA Approval for New CardioMEMS HF System Patient-Facing Capabilities

The US FDA Approves Eli Lilly’s Jaypirca (Pirtobrutinib) for Certain Patients with Previously Untreated CLL/SLL

BMS Reports US FDA Approval of Camzyos in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Roche Secures US FDA Priority Review for Fenebrutinib in both Relapsing and Primary Progressive Multiple Sclerosis

Meitheal Pharmaceuticals Reports US FDA Approval of High-Concentration Formulation of Yusimry (Biosimilar, Humira)

Teva Reports the US FDA Approval of Degevma (Biosimilar, Xgeva)

AbbVie Reports the US FDA Approval of Juvmo (Tavapadon) for Parkinson’s Disease

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