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The US FDA New Drug Approvals in July 2026 

Shots:  The US FDA approved six notable therapies in July 2026 across nephrology, oncology, cardiometabolic disease, ophthalmology, and neuropsychiatry, highlighting continued progress in specialty and chronic disease treatment.   Key approvals included Trutakna (atacicept) for IgA nephropathy, Revtorpyk (gedatolisib) for HR+/HER2- breast cancer, Lipfendra (enlicitide) for hypercholesterolemia, Jideytro (zidesamtinib) for ROS1-positive NSCLC, Lytenava (bevacizumab-vikg) for wet AMD, and Simtriyo (centanafadine) for ADHD, expanding treatment options across diverse patient…

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Alfasigma to Acquire Nordic Pharma, Expanding Rheumatology and Global Reach

Shots: Alfasigma has entered into an agreement with SEVER Life Sciences to acquire 100% of Nordic Pharma & its subsidiaries, adding the Nordimet methotrexate franchise to Alfasigma’s rheumatology portfolio alongside Jyseleca Deal will expand Alfasigma’s commercial footprint through Nordic Pharma’s direct operations across 18 EU countries, while adding platforms in Canada & Japan. The portfolio…

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Oculis to Acquire Full Global Rights to Privosegtor from Accure Therapeutics

Shots: Oculis will acquire Accure’s worldwide development & commercial rights to Privosegtor (ACT-01), terminating its existing license & giving Oculis greater control and economic upside as the neuro-ophthalmology asset advances Deal also incl. ACT-02, a preclinical neurology candidate. Total consideration incl. $3.8M upfront cash & ~2.05M Oculis shares, incl. milestone-linked shares. Closing is expected by…

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Key Biosimilars Events of July 2026 

Shots:  July 2026 witnessed strong momentum across the biosimilars landscape with major regulatory approvals, including Ennumo (US FDA), Garzulys (US FDA), Yesintek Autoinjector (Health Canada), and FDA/EMA acceptance of PB016, alongside commercial launches of Byooviz, Osvyrti, and Jubereq, expanding treatment options across oncology, ophthalmology, immunology, osteoporosis, diabetes, and inflammatory diseases.   Strategic collaborations and licensing agreements between Orion Pharma–Shilpa Biologicals, Polpharma–Teva, Samsung Bioepis–Teva, Formycon–OneSource Specialty Pharma, and Organon–Samsung Bioepis strengthened…

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Outlook Therapeutics Reports the US FDA Approval of Lytenava for Wet AMD 

Shots:  The US FDA has approved Outlook’s Lytenava (Bevacizumab-vikg) for wet AMD    Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized IgG1 MAb targeting VEGF  Additionally, the approval is expected to provide LYTENAVA with 12 years of Reference Product Exclusivity under the BPCIA  Ref:  Outlook Therapeutics |  Image: Outlook Therapeutics |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications.…

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The US FDA New Drug Approvals in June 2026 

Shots:  The US FDA approved three notable therapies in June 2026, spanning diagnostic imaging, infectious diseases, and ophthalmology, highlighting continued progress in precision diagnostics, antimicrobial innovation, and rare disease treatment.  Key approvals included Ambelvist (enhanced MRI detection of lesions), Utebzi (complicated urinary tract infections, including pyelonephritis), and Lumvoa (thyroid eye disease), expanding treatment and diagnostic options for patients with diverse clinical…

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Samsung Bioepis Partners with Teva  to Commercialize Opuviz  (Biosimilar, Eylea) in Canada 

 Shots:  Samsung Bioepis & Teva have entered into a license and commercialization agreement to commercialize Opuviz (Biosimilar, Eylea) in Canada  As per the deal, Samsung Bioepis will be responsible for the registration & manufacture of the products, while Teva Canada will hold commercialization rights  Opuviz was approved by Health Canada in October 2025 for wet AMD, CRVO/BRVO-related macular edema, DME, and mCNV. Samsung Bioepis' aflibercept biosimilar is also marketed in EU and South…

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Key Biosimilars Events of June 2026 

Shots:  June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC),  and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology,  ophthalmology,  oncology, osteoporosis, and reproductive medicine.  Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization.  Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion.  Celltrion Seeks…

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LENZ Therapeutics Partners with Arrotex Pharmaceuticals to Commercialize Vizz in Australia and New Zealand

Shots: LENZ has entered into an exclusive license & commercialization agreement with Arrotex to register & commercialize Vizz (aceclidine ophthalmic solution) 1.44% for the treatment of presbyopia in Australia & New Zealand As per the deal, Arrotex will obtain exclusive commercialization rights for Vizz for the treatment of presbyopia in Australia & New Zealand. In return,…

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Judith Greciet on Targeting Iron Dysregulation: PulseSight’s Next-Generation Approach to Geographic Atrophy  

Shots:  PulseSight Therapeutics is advancing a novel approach to Geographic Atrophy (GA) with PST-611, a first-in-class non-viral gene therapy designed to restore iron homeostasis by targeting transferrin biology—an upstream driver of retinal degeneration.  At ARVO 2026, PST-611 delivered encouraging Phase I results, demonstrating an excellent safety and tolerability profile, stable visual acuity, and early signals of potential functional…

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