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YorLabs Novel Intracardiac Imaging System Cleared

[ Price : $8.95]

FDA clears a YorLabs 510(k) for its new intracardiac imaging system that the company says could reshape workflows in catheterizati...

Inhibrx Posts Positive Phase 3 Results for Ozekibart

[ Price : $8.95]

Inhibrx Biosciences reports favorable data for treating chondrosarcoma with its antibody therapy ozekibart (INBRX-109).

Sumitomo Pharma Gets FDA-483 After Inspection

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FDA posts a two-item Form FDA-483 from an August inspection of Sumitomo Pharmas Suzuka, Japan, manufacturing facility.

FDA Payroll Glitch Delays Pay for Some Exempt Staff

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An FDA payroll system error causes a paycheck delay for some FDA employees who are designated to continue working during the ongoi...

Bayer Dual-Neurokinin Menopause Drug Approved

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FDA approves Bayers Lynkuet (elinzanetant) to treat moderate to severe vasomotor symptoms associated with menopause.

Sydnexis Hit with FDA Rejection for Myopia Drug

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FDA sends Sydnexis a complete response letter for SYD-101, a low-dose atropine eye-drop candidate intended to slow disease progres...

FDA Breakthrough for NRG1+ Cholangiocarcinoma Drug

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FDA grants Partner Therapeutics a breakthrough therapy designation for zenocutuzumab-zbco and its use in treating cholangiocarcino...

Heidelberg Pharmas Myeloma Drug Gets Fast Track

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FDA grants Heidelberg Pharma a fast track designation for HDP-101 (pamlectabart tismanitin), the companys lead antibody drug conju...

Ventyxs Oral NLRP3 Inhibitor Shows Promise in Study

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Ventyx Biosciences reveals positive Phase 2 data for its oral NLRP3 inhibitor VTX3232 in patients with obesity and cardiovascular ...

GSKs Blenrep Approved for Market Reintroduction

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FDA approves a GSK BLA for Blenrep (belantamab mafodotin-blmf) in combination with bortezomib (Velcade) and dexamethasone for trea...