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Argenx
NEWS

Argenx Receives the EC’s Approval for Vyvgart SC to Treat Chronic Inflammatory Demyelinating Polyneuropathy

Shots: The EC has approved Vyvgart (efgartigimod alfa) 1000mg for SC injection as a monotx. for adults with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior corticosteroid or immunoglobulin treatment in all 30 EEA states The EC approval was based on the ADHERE trial, showing 66.5% (214/322) of VYVGART SC-treated pts showed…
June 23, 2025

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Sandoz
NEWS

Sandoz Reports EC’s Approval of Wyost and Jubbonti (Biosimilars, Xgeva and Prolia) 

Shots:  The EC has granted approval to the company’s Wyost and Jubbonti, biosimilar of Xgeva and Prolia (denosumab), across the EU for treating same indications as that of Xgeva and Prolia incl. cancer-related bone disease & osteoporosis, respectively. Their launch is anticipated from Nov 2025 onwards  The EC’s approval was supported by the clinical evaluations…
June 23, 2025

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NEWS

ImmVira Reports First Patient Dosing in P-II Study Evaluating MVR-T3011 in Non-Muscle-Invasive Bladder Cancer (NMIBC) Patients

Shots: ImmVira dosed the first pt with NMIBC in a P-II study evaluating MVR-T3011. Based on approval discussion with the US FDA the company aims to confirm the recommended P-II dose (RP2D) of intravesical administered MVR-T3011 and assess its anti-tumor efficacy in BCG-unresponsive NMIBC pts MVR-T3011 preliminary data presented at ESMO’24 showed a high CRR…
June 11, 2025

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Jazz Pharmaceuticals
NEWS

Jazz Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Zepzelca + Atezolizumab for ES-SCLC

Shots: The US FDA has accepted sNDA & granted priority review seeking full approval of Zepzelca (lurbinectedin) + atezolizumab (Tecentriq) as a 1L therapy for ES-SCLC patients whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposide (PDUFA: Oct 07, 2025) The sNDA was based on P-III (IMforte) trial results, showing Zepzelca +…
June 11, 2025

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NEWS

The US FDA Approves George Medicines’ Widaplik for Hypertension in Adults

Shots: George Medicines’ Widaplik (telmisartan, amlodipine, and indapamide) has been approved by the US FDA for treating adult hypertension, including as initial therapy; launch is anticipated in Q4’25 The approval was supported by two P-III global studies showing Widaplik significantly improved blood pressure and control rates vs PBO & dual drug combinations Widaplik (GMRx2), a…
June 11, 2025

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