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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…

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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…

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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…

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Natera Acquires Foresight Diagnostics for ~$450M to Strengthen Ultrasensitive MRD Testing in Solid Tumors & Lymphoma

Shots: Natera has acquired Foresight Diagnostics, adding its PhasED-Seq phased variant technology with LOD95 of 0.3ppm & detection below 0.1ppm, further enhancing Natera’s capabilities in solid tumor MRD and expanding its IP portfolio of >500 issued/pending patents As per the agreement, Natera completed the acquisition in an all-stock transaction incl. $275M upfront & up to…

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20 Contract Development and Manufacturing Organizations (CDMOs) Of 2025 

Shots:  CDMOs have become central to the modern biopharmaceutical ecosystem, helping companies accelerate development timelines, navigate rising technical complexity, and bring innovative therapies to market with greater efficiency  The global CDMO market continues to post strong double-digit growth and is projected to reach nearly $255B by 2025. This momentum is driven by increased outsourcing, the…

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Top 20 Prescription Drugs of 2025 

Shots:  In 2025, the global Prescription Drugs market is projected to generate an impressive $1.13T, with steady annual growth of 3.94% expected through 2030, ultimately reaching $1.37T. Leading the pack is Keytruda, securing the first position with $29.48B, closely followed by Ozempic at $28.18B, and Eliquis, which recorded $20.69B in global sales. Fourth position is…

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Top 20 Countries in Health Innovation in 2025 

Shots:  Harnessing in-depth research and data-driven insights, PharmaShots unveils its definitive report on the Top 20 Countries in Healthcare Innovation 2025, a comprehensive guide to the nations setting global benchmarks in healthcare advancement  Through a meticulous blend of quantitative and qualitative analysis, PharmaShots delved into the multifaceted dimensions of healthcare innovation, spotlighting emerging trends such…

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Meitheal Pharmaceuticals

Meitheal Pharmaceuticals Receives the US FDA Approval for Contepo (Fosfomycin) Injection to Treat cUTI in Adults

Shots: Meitheal Pharmaceuticals received the US FDA approval for Contepo (fosfomycin) for injection to treat complicated urinary tract infections (cUTI), including acute pyelonephritis in adults caused by E. coli and K. pneumoniae The approval was supported by the P-II/III ZEUS (ZTI-01) study that assessed the safety and efficacy of the treatment on hospitalized pts and…

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