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 Giri2 days ago

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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 Rastogi3 days ago

NEWS

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 Rastogi3 days ago

NEWS

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 Rastogi4 days ago

NEWS

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 Rastogi4 days ago

INSIGHTS+

Key Biosimilars Events of March 2026

Shots: Regulatory momentum remained strong, with key biosimilar launches and approvals including Celltrion’s Remsima IV (EU) and Avtozma SC (US), Teva’s FDA-approved Ponlimsi, Japan’s approval of tocilizumab BS MA by Mochida Pharmaceutical and AYUMI Pharmaceutical, and IND clearance for HLX18 by National Medical Products Administration. Strategic partnerships expanded access, led by Samsung Bioepis–Sandoz collaboration, Formycon’s aflibercept settlement deal with Regeneron Pharmaceuticals and Bayer, and Bio-Thera…

ByDipanshu Dixit5 days ago

NEWS

The US FDA Accepts Ultragenyx’s Resubmitted BLA for UX111 in Sanfilippo Syndrome Type A

Shots: The US FDA has accepted the resubmitted BLA of UX111 (rebisufligene etisparvovec) for accelerated approval in Sanfilippo syndrome Type A (MPS IIIA), with a PDUFA action date of Sep 19, 2026 UX111 BLA is supported by up to 8yrs. of follow-up data showing durable clinical benefit & acceptable safety. Also, during prior late-cycle review,…

ByRidhi RastogiApril 6, 2026

NEWS

Allevion Secures FDA Clearance for Vantage Spinal Decompression System

Shots: The US FDA has granted 510K Clearance to Vantage, a fully disposable, sterile system designed for minimally invasive lumbar decompression procedures Vantage features a structured “locate, dilate, decompress” workflow with integrated illumination for direct visualization, enabling precise, depth-controlled bone resection while improving procedural consistency & safety The single-use system eliminates the need for reusable…

ByRidhi RastogiApril 6, 2026

NEWS

Regeneron Wins US FDA Approval for Eylea HD with Up to 5-Month Dosing in wAMD and DME

Shots: FDA has approved extending Eylea HD dosing intervals up to 20wks. for wet age-related macular degeneration (wAMD) & diabetic macular edema (DME) after 1yr. of response based on visual & anatomic outcomes As a part of approval, the Eylea HD label will incl. 96wk. PULSAR (wAMD; n=583) & PHOTON (DME; n=395) data, where 71%…

ByRidhi RastogiApril 6, 2026

NEWS

Zeto Receives US FDA 510(k) Clearance for Zeto New Wave to Advance Outpatient EEG

Shots: The US FDA has granted 510(k) clearance to Zeto New Wave to perform EEG efficiently in outpatient clinics & homes Zeto New Wave is an easy-to-use outpatient EEG system with 21 soft-tip electrodes (10–20 system), offering full head coverage & paired with a compact device capturing synchronized video/audio Designed for short-term recordings up to 2.5hrs., the…

ByRidhi RastogiApril 3, 2026

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

Key Biosimilars Events of March 2026

The US FDA Accepts Ultragenyx’s Resubmitted BLA for UX111 in Sanfilippo Syndrome Type A

Allevion Secures FDA Clearance for Vantage Spinal Decompression System

Regeneron Wins US FDA Approval for Eylea HD with Up to 5-Month Dosing in wAMD and DME

Zeto Receives US FDA 510(k) Clearance for Zeto New Wave to Advance Outpatient EEG

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