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NEWS

The US FDA Approves Edwards Lifesciences’ SAPIEN M3 Mitral Valve Replacement System for Mitral Regurgitation

Shots: The US FDA has approved Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement (TMVR) system as the transseptal transcatheter therapy for the treatment of symptomatic moderate-to-severe or severe mitral regurgitation (MR) SAPIEN M3 is indicated for pts unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy, including those with mitral valve dysfunction associated with…
December 25, 2025

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NEWS

Zydus Partners with Bioeq for US Commercialization of Nufymco (Biosimilar, Lucentis)

Shots: Zydus Lifesciences has entered into a strategic licensing, supply & commercialization agreement with Bioeq for Nufymco (ranibizumab), an interchangeable biosimilar to Lucentis, for the US market, marking an expansion of Zydus’ US biosimilar portfolio Under the agreement, Bioeq will handle development, manufacturing, registration & supply of the finished product while Zydus will lead US…
December 25, 2025

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TOP 20

20 AI Healthcare Companies of 2025  

Shots:  AI is revolutionizing healthcare, reshaping drug discovery, protein design, and precision therapeutics. Companies are now tackling previously “undruggable” targets and moving treatments through development pipelines faster than ever  The AI in the healthcare market is exploding. From a valuation of $26.57B in 2024, it is projected to reach $505.59B by 2033, growing at a CAGR of 38.8%. This rapid…
December 18, 2025

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TOP 20

Top 20 Animal Health Companies of 2025 

Shots:  Animal health companies remain fundamental to global veterinary care and modern food production, driving innovation across pharmaceuticals, vaccines, diagnostics, and digital technologies that support the health of both companion animals and livestock  The sector continues to deliver robust, steady growth, fueled by rising pet ownership, increasing demand for safe and sustainable protein, and rapid…
December 12, 2025

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NEWS

Resmed Receives FDA Clearance for Smart Comfort, an AI-Enabled Tool to Personalize CPAP Therapy

Shots: Resmed received FDA clearance for its AI-enabled Smart Comfort for PTCS (Personalized Therapy Comfort Settings), the first FDA-cleared device for personalized comfort settings for obstructive sleep apnea (OSA) pts start and stay on CPAP therapy US rollout begins in limited beta versions for new users of myAir users in early 2026, followed by broader availability…
December 9, 2025

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NEWS

EyeYon Medical Receives the US FDA’s IDE Approval to Initiate US Study of EndoArt for Chronic Corneal Edema

Shots: EyeYon Medical secured FDA IDE approval to initiate the first US clinical study of EndoArt, a synthetic endothelial layer and an FDA-designated Breakthrough Device for chronic corneal edema The study will involve 10+ leading US cornea surgeons, evaluating EndoArt as a novel alternative for patients unsuitable for human tissue implantation EndoArt has already seen…
December 9, 2025

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NEWS

Orca Bio Presents New Clinical Data On Orca-Q and Orca-T/CAR-T Combination Therapy at ASH 2025

Shots: Orca Bio reported positive P-I study data for Orca-Q, showing rapid neutrophil recovery, low acute/chronic GvHD, reduced infections, and low non-relapse mortality, including in patients treated without any GvHD prophylaxis Patients receiving Orca-Q with tacrolimus (Arm A, n=18) vs. without immunosuppression (Arm C, n=26) showed comparable survival and GvHD outcomes, with faster neutrophil engraftment…
December 9, 2025

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NEWS

Junshi Biosciences Reports NMPA Acceptance of the NDA for Roconkibart (IL-17A) to Treat Moderate to Severe Plaque Psoriasis

Shots: Junshi Biosciences reported that the NMPA has accepted the NDA for roconkibart injection (JS005), for adults with moderate to severe plaque psoriasis eligible for systemic therapy or phototherapy The submission is backed by a multicenter P-III study (n=747) showing significant improvements in PASI 75/90/100 and sPGA 0/1 vs PBO at 12wks., with sustained efficacy…
December 8, 2025

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