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Representative image illustrating ophthalmic gene therapy research and retinal disease treatment. Israel’s early access approval for GS010/LUMEVOQ highlights shifting regulatory pathways for rare vision‑loss conditions like Leber Hereditary Optic Neuropathy.
Pharma & Biotech

GenSight Biologics gets green light for GS010 in Israel: What this means for LHON patients and regulators

GenSight Biologics S.A. has received approval from Israel’s Ministry of Health to provide early access treatment with its investigational gene therapy GS010/LUMEVOQ (lenadogene nolparvovec) for individual patients diagnosed with ND4-related Leber Hereditary Optic Neuropathy (LHON). This authorization permits bilateral intravitreal injections under compassionate use protocols, with treatments expected to begin in the first quarter of

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Representative image illustrating antibody-targeted therapy in lymphoma treatment, relevant to Japan’s approval of tafasitamab for relapsed follicular lymphoma.
Pharma & Biotech

Incyte’s Minjuvi combo gets Japan approval for relapsed follicular lymphoma

Incyte Biosciences Japan has secured approval from the Ministry of Health, Labour and Welfare for the use of Minjuvi (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma. This marks the first regulatory authorization in Japan for a CD19-directed therapy in this indication and introduces a novel CD19–CD20

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Representative image of a pre-filled syringe and vial, symbolizing the upcoming European launch of Samsung Bioepis' BYOOVIZ biosimilar to Lucentis in ophthalmology care.
Pharma & Biotech

Samsung Bioepis takes over BYOOVIZ commercialization in Europe after Biogen exit

Samsung Bioepis has officially begun direct commercialization of BYOOVIZ, a biosimilar to Lucentis (ranibizumab), across Europe following the complete transfer of rights from Biogen. The move makes BYOOVIZ the fourth biosimilar now independently marketed by Samsung Bioepis in the region, joining EPYSQLI (eculizumab), OBODENCE (denosumab), and XBRYK (denosumab). The company also confirmed that a pre-filled

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Representative image showing radiation-induced skin toxicity, a growing challenge in oncology care. Hoth Therapeutics is targeting this unmet need with HT-001, aiming to redefine supportive treatment in oncodermatology.
Pharma & Biotech

Hoth Therapeutics makes strategic IP move to tackle radiation and targeted therapy skin toxicities

Hoth Therapeutics, Inc. has filed two provisional U.S. patents for its investigational therapy HT-001, aiming to address skin toxicities caused by radiation and targeted cancer therapies. The dual filings mark a deliberate expansion into oncology-adjacent dermatology, establishing a new intellectual property footprint around treatment-induced skin damage, including adverse effects linked to menin inhibitors. This signals

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Pharma & Biotech

Can gut-restricted PDE4 inhibitors transform treatment for ulcerative colitis and Crohn’s?

Palisade Bio’s PALI-2108 secures a Japanese patent. Explore how this gut-targeted PDE4 inhibitor could change the game in ulcerative colitis and Crohn’s.

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Pharma & Biotech

Can BioAtla’s Oz-V set a new standard in ROR2-targeted therapy for head and neck cancer?

BioAtla and GATC Health advance Ozuriftamab Vedotin into a Phase 3 trial for OPSCC via SPV financing. Discover how this targets cancer and aging together.

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Pharma & Biotech

Serum Institute exits IXCHIQ rollout as Valneva resets LMIC strategy

Valneva ends its chikungunya vaccine deal with Serum Institute of India. Find out what this means for Asian access, LMIC rollout, and CEPI commitments.

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Pharma & Biotech

Outlook’s bevacizumab for wet AMD rejected again: What’s holding back FDA approval?

FDA rejects Outlook Therapeutics’ ONS-5010 for wet AMD again. Find out what this means for U.S. approval and how European expansion could reshape strategy.

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Pharma & Biotech

GoldenTree backs Alvotech with $100m financing to accelerate pipeline execution

Alvotech secures $100M loan to fund 2026 biosimilar launches and R&D. Find out how this financing reshapes its global strategy.

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Pharma & Biotech

How XORTX is linking gout to genetics and reshaping the future of precision uric acid therapies

XORTX is using new genetic research to strengthen its case for oxypurinol in gout and kidney disease. Find out how this could shape the future of precision nephrology.

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