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The US FDA has approved the Altaviva device, an implantable tibial neuromodulation therapy to treat urge urinary incontinence
Altaviva device is placed under the skin above the fascia & near…
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The CHMP has recommended Nipocalimab as an add-on therapy to treat anti-AChR Ab+ & anti-MuSK Ab+ gMG pts (≥12yrs.)
Opinion was based on the P-III (Vivacity-MG3) trial assessing nipocalimab (30mg/kg,…
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The EC has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product
Approval was based on extensive…
PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, M&A and Biosimilars. Check…
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Avant Technologies and Austrianova signed a joint venture and licensing agreement to form Klothonova, a 50/50 Nevada-based Joint Venture focused on developing cell-based therapies using encapsulated Klotho-producing cells
Under…
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Biogen has entered into a definitive agreement to acquire Alcyone Therapeutics, building on its partnership to advance ThecaFlex DRx
As per the deal, Biogen will acquire Alcyone Therapeutics for…
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Intellia Therapeutics completed enrollment in the global P-III (HAELO) study evaluating lonvo-z for treating HAE, finishing within 9mos. since the first patient was dosed in Jan 2025, with nearly…
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Health Canada has approved Stoboclo & Osenvelt (CT-P41), referencing biosimilar Prolia & Xgeva, for all approved indications of the reference drugs
Approval was supported by P-III trial data in…