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Arcutis Biotherapeutics
NEWS

Arcutis Biotherapeutics Reports the US FDA’s sNDA Acceptance of Zoryve (Roflumilast) to Treat Plaque Psoriasis (PsO) in Children

Shots: The US FDA has accepted the sNDA of Zoryve (0.3% roflumilast cream) for the treatment of children (2-5yrs.) with PsO (PDUFA: Jun 29, 2026) The sNDA is supported by a 4wk. MUSE study in children (2-5yrs.) with PsO & a long-term open-label study showing consistent favorable safety, tolerability, & sustained efficacy across all age…
November 18, 2025

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Ionis and Otsuka
NEWS

The CHMP Recommends Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The CHMP has recommended Dawnzera for the routine prevention of HAE attacks in pts (≥12yrs.) following the US FDA approval in Aug 2025; EC’s decision is expected in Q1’26 Opinion was based on P-III (OASIS-HAE) trial & OASISplus study, showing improvements across multiple domains, incl. sustained reduction in mean monthly HAE attack rate even when Dawnzera…
November 17, 2025

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NEWS

Outlook Therapeutics Reports the US FDA’s BLA Acceptance of ONS-5010 to Treat Wet Age-Related Macular Degeneration (wAMD)

Shots: The US FDA has accepted the resubmitted BLA of ONS-5010 (bevacizumab-vikg) for the treatment of wAMD, considering a Class 1 review & granting a PDUFA goal date Dec 31, 2025; if approved, it will be branded Lytenava ONS-5010 (intravitreal) is an ophthalmic bevacizumab formulation that binds all VEGF isoforms to block VEGF interaction with…
November 14, 2025

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Kura Oncology and Kyowa Kirin
NEWS

Kura Oncology and Kyowa Kirin Report the US FDA’s Approval Komzifti (Ziftomenib) for NPM1-Mutated Acute Myeloid Leukemia (AML)

Shots: The US FDA has granted full approval to Komzifti (QD, PO) to treat adults with r/r AML with NPM1 mutation who have no satisfactory alternative treatment options before the PDUFA date of Nov 30, 2025 Approval was backed by P-I/II (KOMET-001) trial in 112 r/r NPM1-mutant AML pts, showing 21.4% CR + CRh with a median…
November 14, 2025

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NEWS

Rapid Nexus Reports the US FDA’s 510(k) Clearance of Hemastyl Gel Device to Support Wound Healing

Shots: The US FDA has granted 510(k) clearance to the Hemastyl gel device to support chronic wound healing  The Hemastyl gel is a topical formulation that enhances the tissue-repair environment to support wound closure, while the Periwound NerveStim device works with Hemastyl to restore periwound function The Periwound NerveStim device is in final FDA approval stages, with…
November 14, 2025

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ITM
NEWS

ITM Reports the US FDA’s NDA Acceptance for ¹⁷⁷Lu-edotreotide to Treat Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Shots: The US FDA has accepted an NDA of 177Lu-edotreotide (ITM-11) for the treatment of GEP-NETs, with a PDUFA goal date of Aug 28, 2026 NDA was supported by the P-III (COMPETE) trial assessing ITM-11 vs everolimus (N=309) as a 1/2L treatment of inoperable, progressive, SSTR+ Grade 1 or 2 GEP-NETs, which met its 1EP of…
November 13, 2025

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NEWS

Thermo Fisher Scientific’s EXENT System Receives the US FDA’s 510(k) Clearance to Aid Multiple Myeloma Diagnosis

Shots: Thermo Fisher Scientific has received FDA 510(k) clearance for the EXENT Analyser & Immunoglobulin Isotypes (GAM) Assay, an automated mass spectrometry-based platform, for aiding diagnosis of MM & related conditions The EXENT System detects & isotypes low-concentration M-proteins with high sensitivity to identify them by molecular weight, differentiating endogenous from therapeutic antibodies & providing…
November 13, 2025

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NEWS

Promega’s OncoMate MSI Dx Analysis System Receives FDA Approval as a Companion Diagnostic

Shots: The US FDA has approved OncoMate MSI Dx Analysis System as a companion diagnostic to identify pts with microsatellite stable endometrial carcinoma The OncoMate MSI Dx Analysis System is a PCR-based assay that determines MSI status in tumors to identify pts eligible for treatment with Keytruda (pembrolizumab) & Lenvima (lenvatinib) OncoMate MSI Dx Analysis System…
November 12, 2025

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