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Nuevocor Reports the US FDA’s IND Clearance of NVC-001 for LMNA DCM
Shots: The US FDA has approved the IND application of NVC-001 to treat LMNA-related dilated cardiomyopathy (LMNA DCM), enabling a P-I/II trial to start in early 2026 Preclinical studies showed that NVC-001 significantly improved survival and cardiac function. They planned a P-I/II trial, a 52-week, open-label, multicenter ascending-dose study to assess the safety, tolerability, and…
June 11, 2025
OS Therapies & EVERSANA Partner to Commercialize OST-HER2 in the US for Pediatric Osteosarcoma
Shots: OS Therapies joined hands with EVERSANA to commercialize OST-HER2 in the US for the treatment of pediatric lung metastatic osteosarcoma This partnership leverages EVERSANA’s integrated commercialization platform, including market access, medical affairs, field deployment, patient services, and stakeholder engagement enabling OS Therapies to bring OST-HER2 to market rapidly and cost-effectively OS Therapies recently secured…
June 11, 2025
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
Jazz Pharmaceuticals
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
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
Merck new
The US FDA Approves Merck’s ENFLONSIA for RSV Prevention in Infants
Shots : Merck’s ENFLONSIA has been approved by the US FDA to prevent RSV lower respiratory tract disease in newborns and infants entering their first RSV season, offering protection for up to 5mos. with a single 105mg dose, regardless of weight The approval was supported by the P-IIb/III (CLEVER) study of ENFLONSIA that demonstrated reduced…
June 10, 2025
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