NEWS

Medtronic Receives the US FDA clearance for Hugo RAS system for Urologic Surgical Procedures

Shots: The US FDA has granted clearance to Hugo robotic-assisted surgery (RAS) system for use in minimally invasive urologic surgical procedures, incl. prostatectomy, nephrectomy, & cystectomy The Hugo RAS system met its primary safety & efficacy endpoints in the Expand URO IDE study, showing performance in urologic procedures consistent with outcomes reported in published literature…

December 4, 2025

Formycon Partners with MS Pharma to Commercialize FYB206 (Biosimilar, Keytruda) in the MENA Region

Shots: Formycon has entered into an exclusive licensing & supply agreement with MS Pharma for the commercialization of Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the MENA region As per the deal, Formycon will receive an upfront payment, potential development & regulatory milestones, & a significant share of regional gross profits, though…

December 4, 2025

Capricor Therapeutics Reports the Topline P-III (HOPE-3) Trial Data on Deramiocel for Duchenne Muscular Dystrophy

Shots: Capricor Therapeutics has reported the topline P-III (HOPE-3) trial data assessing Deramiocel (IV, Q3M) vs PBO in boys & young men (n=106) with DMD for 12mos. across the US Trial met its 1EP with a 54% slowing of upper-limb functional decline (PUL v2.0) among 105 evaluable pts at 12mos. & achieved its 2EP with…

December 4, 2025

Iolyx Therapeutics Enters a Strategic Deal with Laboratoires Théa for ILYX-002 to Treat Ocular Surface Conditions

Shots: Iolyx has granted Théa exclusive global rights (excl. Asia) to develop & commercialize ILYX-002 for Dry Eye Disease associated with systemic autoimmune disorders & other ocular surface conditions Iolyx will receive ~$280M in clinical, regulatory, & commercial milestones; tiered royalties up to ~21%; & R&D cost reimbursement. Iolyx will design P-III trials, handle manufacturing,…

December 4, 2025

Eli Lilly’s Jaypirca Receives the FDA Approval for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Shots: The US FDA has approved label expansion of Jaypirca (pirtobrutinib; 100 & 50mg) for the treatment of adults with r/r CLL/SLL who were previously treated with a covalent BTK inhibitor & converted the accelerated approval of Dec 2023 to a full approval Label expansion was based on the P-III (BRUIN CLL-321) study assessing Jaypirca…

December 4, 2025

Formosa Pharmaceuticals Collaborates with Rxilient to Commercialize APP13007 Across ASEAN Markets

Shots: Formosa has entered into an exclusive licensing agreement with Rxilient to commercialize APP13007, a 0.05% clobetasol propionate ophthalmic suspension for the treatment of inflammation & pain after ocular surgery As per the deal, Rxilient will gain exclusive rights to commercialize the suspension across key ASEAN markets, incl. Indonesia, Philippines, Singapore, & Thailand, with the deal…

December 3, 2025

Imvax Reports P-IIb Trial Findings on IGV-001 to Treat Newly Diagnosed Glioblastoma

Shots: Imvax has reported the topline data from the P-IIb trial assessing IGV-001 vs PBO in 99 pts with newly diagnosed glioblastoma (ndGBM) Trial showed an mOS of 20.3 vs 14mos., with an mFU of 22mos. for all pts, plus IGV-001 demonstrated measurable patient benefit across various metrics; safety was consistent with previous studies Additionally,…

December 3, 2025

Ionis’ Zilganersen Receives the US FDA’s Breakthrough Therapy Designation for Alexander Disease

Shots: The US FDA has granted BTD to zilganersen for the treatment of Alexander disease (AxD) Designation was supported by the topline P-III trial data, which assessed zilganersen (25 or 50mg) vs control in 54 AxD pts (1.5-53yrs.). Zilganersen (50mg) met the 1EP of gait speed as assessed by 10-Meter Walk Test at 61wks., plus…

December 3, 2025

Francis Medical’s Vanquish Water Vapor System Receives the US FDA 510(k) Clearance for Prostate Tissue Ablation

Shots: FDA has granted 510(k) clearance to Vanquish Water Vapor System for prostate tissue ablation in pts with intermediate-risk, localized prostate cancer Clearance was supported by 12mos. follow-up data on 110 pts first enrolled in the ongoing VAPOR 2 trial (n=235) assessing Vanquish System across the US, with longer-term to support PMA submission 6mos. biopsy…

December 3, 2025

The US FDA Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

Shots: The US FDA has approved Omlyclo, an interchangeable biosimilar version of Xolair (omalizumab), in PFS presentation (300mg/2ml, SC) for the treatment of pts with allergic asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps (CRSwNP), & IgE-mediated food allergy Omlyclo previously received the US FDA approval in Mar 2025 for PFS injections at…

December 3, 2025

NEWS

Medtronic Receives the US FDA clearance for Hugo RAS system for Urologic Surgical Procedures

Formycon Partners with MS Pharma to Commercialize FYB206 (Biosimilar, Keytruda) in the MENA Region

Capricor Therapeutics Reports the Topline P-III (HOPE-3) Trial Data on Deramiocel for Duchenne Muscular Dystrophy

Iolyx Therapeutics Enters a Strategic Deal with Laboratoires Théa for ILYX-002 to Treat Ocular Surface Conditions

Eli Lilly’s Jaypirca Receives the FDA Approval for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Formosa Pharmaceuticals Collaborates with Rxilient to Commercialize APP13007 Across ASEAN Markets

Imvax Reports P-IIb Trial Findings on IGV-001 to Treat Newly Diagnosed Glioblastoma

Ionis’ Zilganersen Receives the US FDA’s Breakthrough Therapy Designation for Alexander Disease

Francis Medical’s Vanquish Water Vapor System Receives the US FDA 510(k) Clearance for Prostate Tissue Ablation

The US FDA Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

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