Category - Developments

Developments

FDA grants clearance for Nanox.ARC expanding application to pulmonary and general use

Nanox Imaging (NASDAQ:NNOX) has announced that its Nanox.ARC stationary X-ray system has received 510(k) clearance from the FDA, allowing general use including the human musculoskeletal system, pulmonary, intra...

December 6, 2024

Developments

FDA grants RMAT for combination of Affimed’s acimtamig and Artiva’s AlloNK

Affimed (NASDAQ:AFMD) announced that the FDA has granted regenerative medicine advanced therapy (RMAT) designation to its combination therapy involving Affimed’s innate cell engager (ICE) acimtamig, and Artiva...

December 5, 2024

Developments

Nkarta receives IND clearance for IST in MG; launches enrollment of Ntrust-2 trial

Nkarta (NASDQ:NKTX) announced the clearance of an investigational new drug clearance (IND) application for its investigator-sponsored trial (IST) evaluating NKX019 in patients with myasthenia gravis (MG), alongside the...

December 5, 2024

Developments

Cartesian reports promising results from Phase 2b trial of Descartes-08 in MG

Cartesian Therapeutics (NASDAQ:RNAC) announced updated efficacy and safety data from its Phase 2b trial of Descartes-08 in myasthenia gravis (MG), showing deep, durable responses without the need for chemotherapy. The...

December 4, 2024

Developments

Medicus enters agreement with Swanielle to expand Phase 2 trial in APAC

Medicus Pharma (NASDAQ:MDCX) (TSXV:MDCX) announced a collaborative agreement with Swanielle to explore the expansion of its SKNJCT-003 Phase 2 clinical study for the treatment of basal cell carcinoma in the Asia-Pacific...

December 2, 2024

Developments

FDA accepts Revelation’s IND for Gemini in CKD

Revelation Biosciences (NASDAQ:REVB) announced that the FDA has accepted its investigational new drug (IND) application for Gemini in chronic kidney disease (CKD). The company notes that the milestone enables the launch...

December 2, 2024

Developments

Elite launches generic hydrocodone and acetaminophen tables for pain management

Elite Pharmaceuticals (OTCQB:ELTP) announced it has launched a generic version of Norco tablets, a combination of hydrocodone bitartrate and acetaminophen for pain management. The generic hydrocodone bitartrate and...

December 2, 2024

Developments

Profound Medical and Siemens Healthineers to Offer a Complete Solution for MRI-guided Prostate Therapy

Profound Medical (NASDAQ:PROF; TSX:PRN) announced a definitive co-sales and co-marketing agreement with Siemens Healthineers (XETRA:SHL) pursuant to which the companies will commercialize a new MRI-guided prostate...

December 2, 2024

Developments

CervoMed’s stock rises as FDA grants ODD to neflamapimod for dementia

CervoMed (NASDAQ:CRVO) announced that the FDA has granted orphan drug designation (ODD) to its lead investigational therapy, neflamapimod, for the treatment of frontotemporal dementia (FTD). Following the announcement...

November 28, 2024

Developments

Perimeter showcases ASBrS webinar focused on margin assessment using OCT during breast cancer surgery

Perimeter Medical Imaging AI (TSX-V: PINK; OTC: PYNKF) highlighted the November 26, 2024 webinar entitled, “Clearer Margins. Greater Confidence. Exploring the Benefits of OTC”, sponsored by the American Society of...

November 27, 2024

Category - Developments

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