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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, 20250Comments

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Jazz Pharmaceuticals
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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, 20250Comments

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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, 20250Comments

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TYBR Health’s B3 GEL System Receives the US FDA’s 510(k) Clearance to Protect Healing Tissue and Preserve Function

Shots: The US FDA has granted 510(k) clearance to the B3 GEL System to protect healing tissue planes and preserve mobility; launch is anticipated at the end of 2025 Preclinical studies supporting clearance showed that B3 GEL reduced tissue binding and improved range of motion, with greater flexion and extension in treated models compared to controls…
June 10, 20250Comments

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Merck Kga
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NMPA Accepts Marketing Authorization for Merck KGaA’s Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Shots: The NMPA has accepted the MAA of Pimicotinib (QD) for adults with TGCT needing systemic therapy The application was based on Part 1 of the P-III (MANEUVER) global study, trial assessed pimicotinib (n=63) vs PBO (n=31) for 24wks. in 94 TGCT pts who required systemic therapy & had no prior anti-CSF-1/CSF-1R treatment, the trial also…
June 10, 20250Comments

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Alnylam Pharmaceuticals’ Amvuttra Receives the EC’s Approval for ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

Shots: The EC has approved Amvuttra (vutrisiran) to treat ATTR-CM adults  as an additional indication, based on the global P-III (HELIOS-B) study assessing it vs PBO in ATTR-CM pts The study met all ten 1 & 2EPs across both overall & monotx. arms, showing improved outcomes of mortality, CV events & functional capacity with 6min. walk…
June 10, 20250Comments

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