SN BioScience Receives US FDA ODD for SNB-101 in Gastric Cancer

Shots: US FDA has granted Orphan Drug Designation (ODD) to SN BioScience’s SNB-101 for the treatment of gastric cancer, including gastroesophageal junction cancer SNB-101 is currently under P-Ib/II development for small cell lung cancer and is being evaluated across multiple solid tumor indications in Korea, Europe and US SNB-101 is a polymer nanoparticle formulation of…

ByPrince GiriDecember 25, 2025

NEWS

Foresee Pharmaceuticals Reports P-III (Casppian) Study Data of FP-001 in Children with CPP

Shots: Foresee Pharmaceuticals reported its P-III (Casppian) Study data of FP-001 (leuprolide mesylate 42mg; administered every six months), a sustained-release GnRH agonist, met its 1EP in children with central precocious puberty (CPP) The study showed that 94% of pts achieved serum LH suppression to <4 mIU/mL at 60 mins. following a GnRHa stimulation test at Wk.…

ByPrince GiriDecember 25, 2025

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…

ByPrince GiriDecember 25, 2025

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…

ByPrince GiriDecember 25, 2025

NEWS

Roche Receives the US FDA Approval of Lunsumio VELO for Subcutaneous Use in R/R Follicular Lymphoma

Shots: The US FDA has approved Roche’s Lunsumio VELO (mosunetuzumab) as an SC formulation for the treatment of adults with r/r follicular lymphoma (FL) after ≥2L of systemic therapy, under accelerated approval Approval was based on the P-I/II (GO29781) study in third-line or later FL pts, where Lunsumio VELO demonstrated an ORR of 75% and…

ByPrince GiriDecember 23, 2025

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…

ByPrince GiriDecember 18, 2025

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…

ByPrince GiriDecember 12, 2025

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…

ByPrince GiriDecember 9, 2025

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…

ByPrince GiriDecember 9, 2025

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…

ByPrince GiriDecember 9, 2025

Prince Giri

SN BioScience Receives US FDA ODD for SNB-101 in Gastric Cancer

Foresee Pharmaceuticals Reports P-III (Casppian) Study Data of FP-001 in Children with CPP

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

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

Roche Receives the US FDA Approval of Lunsumio VELO for Subcutaneous Use in R/R Follicular Lymphoma

20 AI Healthcare Companies of 2025

Top 20 Animal Health Companies of 2025

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

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

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

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