Protaryx Medical Secures FDA Clearance for its Transseptal Access Device

Shots: The US FDA has granted 510(k) clearance to the Transseptal Puncture Device to advance minimally invasive access for left-heart procedures, with plans to begin US commercialization The Device is a next-gen system enabling zero-exchange access to the left heart, integrating RF guidewire tech with standard electrosurgical generators & an echogenic, extendable atraumatic probe to…

ByRidhi RastogiApril 14, 2026

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Travere Therapeutics Reports FDA Full Approval of Filspari for Proteinuria Reduction in FSGS

Shots: The US FDA has granted full approval to Filspari (sparsentan) to reduce proteinuria in pts (≥8yrs.) with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome Approval was based on the global P-III (DUPLEX) trial assessing Filspari vs irbesartan in 371 pts (8–75 yrs.) with biopsy-proven or genetic FSGS, following a 2wk. washout, with dose titration…

ByRidhi RastogiApril 14, 2026

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Daiichi Sankyo and Merck Receives FDA’s Priority Review for Ifinatamab Deruxtecan (I-DXd) to Treat ES-SCLC

Shots: FDA has accepted BLA for I-DXd under the RTOR & Project Orbis program, granting priority review for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed on or after Pt-based CT (PDUFA: Oct 10, 2026) BLA was based on the P-II (IDeate-Lung01) study assessing I-DXd (IV, Q3W) in…

ByRidhi RastogiApril 14, 2026

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Miracell Reports US FDA 510(k) Clearance for SMART M-CELL PRP and Bone Marrow Concentration Systems

Shots: The US FDA has granted 510(k) clearance to Miracell’s SMART M-CELL PRP Concentration System and Bone Marrow Concentration System, including associated blood and bone marrow kits Clearance was based on substantial equivalence to SmartPReP, with the system demonstrating high cell viability, efficient growth factor extraction, and integrated performance across centrifuge and kit components SMART…

ByPrince GiriApril 13, 2026

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Eli Lilly Launches Foundayo (Orforglipron) for Weight Loss in the US

Shots: Eli Lilly has reported that Foundayo is now available in the US, along with lifestyle intervention for obese/overweight adults with weight-related medical problems. Foundayo is now available via LillyDirect and telehealth, with US retail rollout starting today Approval was backed by the ATTAIN program, including ATTAIN-1 (n= 3127), where Foundayo showed weight loss of…

ByDipanshu DixitApril 13, 2026

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Telix Reports US FDA Acceptance of NDA for TLX101-Px (Pixclara) in Glioma Imaging

Shots: The US FDA has accepted the resubmitted NDA for TLX101-Px (Pixclara; 18F-FET), an investigational PET imaging agent for the detection and characterization of glioma in adult and pediatric patients The US FDA has assigned a PDUFA date of 11’Sep, 2026; TLX101-Px has received Orphan Drug and Fast Track designations, addressing unmet needs in distinguishing…

ByPrince GiriApril 10, 2026

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Waters Expands Cervical Cancer Screening Access with at-Home HPV Test Approval

Shots: The US FDA has granted clearance to the Onclarity HPV Self-Collection Kit & approved the BD Onclarity HPV Assay for at-home use, expanding access to cervical cancer screening The kit is tested with the BD Onclarity HPV Assay, detecting all high-risk HPV genotypes with individual & pooled results, & processed on the automated BD…

ByRidhi RastogiApril 9, 2026

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Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Risk of Cardiac Amyloidosis Early

Shots: The US FDA has granted clearance to ECG-AI algorithm, a software-as-a-medical-device designed for cardiac amyloidosis (CA), cleared for use with standard 12-lead ECGs ECG-AI algorithm analyzes ECG waveforms to detect CA-related patterns not visible to clinicians, integrating into existing workflows using routine ECGs without additional testing to help identify at-risk pts & guide next…

ByRidhi RastogiApril 9, 2026

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Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC

Shots: The US FDA has received the NDA of neladalkib for the treatment of TKI pre-treated pts with advanced ALK-positive NSCLC NDA was supported by global P-I/II (ALKOVE-1) trial of neladalkib in TKI-pretreated advanced ALK-positive NSCLC, showing favorable activity incl. intracranial responses, targeting key progression drivers, & a generally well-tolerated safety profile; data to be…

ByRidhi RastogiApril 8, 2026

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Endospan’s Nexus System Receives the US FDA Approval to Treat Aortic Arch Disease

Shots: The US FDA has approved the Nexus Aortic Arch Stent Graft for the treatment of aortic arch disease Approval was supported by the 1yr. results from the TRIOMPHE IDE trial assessing Nexus in aortic arch disease, incl. chronic aortic dissections, in pts at high risk for open surgical repair, which showed safe & effective treatment in…

ByRidhi RastogiApril 8, 2026

Protaryx Medical Secures FDA Clearance for its Transseptal Access Device

Travere Therapeutics Reports FDA Full Approval of Filspari for Proteinuria Reduction in FSGS

Daiichi Sankyo and Merck Receives FDA’s Priority Review for Ifinatamab Deruxtecan (I-DXd) to Treat ES-SCLC

Miracell Reports US FDA 510(k) Clearance for SMART M-CELL PRP and Bone Marrow Concentration Systems

Eli Lilly Launches Foundayo (Orforglipron) for Weight Loss in the US

Telix Reports US FDA Acceptance of NDA for TLX101-Px (Pixclara) in Glioma Imaging

Waters Expands Cervical Cancer Screening Access with at-Home HPV Test Approval

Anumana Secures the US FDA 510(k) Clearance for its ECG-AI Algorithm to Detect Risk of Cardiac Amyloidosis Early

Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC

Endospan’s Nexus System Receives the US FDA Approval to Treat Aortic Arch Disease

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