Mabwell Initiates P-III Trial for 9MW2821 in TNBC

Shots: Mabwell has initiated a P-III trial of 9MW2821 in triple-negative breast cancer (TNBC), marking the fourth pivotal study for 9MW2821 The trial will assess the efficacy of 9MW2821 vs the investigator’s choice chemotherapy in locally advanced or metastatic TNBC pts previously treated with taxane-based CT ± immunotherapy & a topoisomerase inhibitor-based ADC 9MW2821, a…

ByRidhi RastogiApril 24, 2026

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FLEX Vascular Presents 12-month Real-World Data for FLEX Vessel Prep System at CX Symposium 2026

Shots: FLEX Vascular reported 12mos. results from the FLEX FIRST AV Registry at Charing Cross Symposium 2026, showing strong safety with 0% serious adverse events at 30 days & durable performance in hemodialysis access patients The study (n=130) demonstrated 40% primary patency in cephalic arch lesions & 100% secondary patency in AV grafts at 12mos.,…

ByRidhi RastogiApril 24, 2026

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Johnson & Johnson Reports Clinical Findings on Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG) at AAN 2026

Shots: J&J has reported data from the P-III (Vivacity-MG3) trial assessing Imaavy + SoC (n=77) vs PBO + SoC (n=76) in gMG pts (N=199; 153 were Ab +ve), plus from an ongoing OLE trial. Also, enrolment is ongoing in the EPIC trial of Imaavy against efgartigimod The 24wk. Post-hoc analysis data showed adults receiving Imaavy…

ByRidhi RastogiApril 24, 2026

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Regeneron Reports the US FDA Accelerated Approval of Otarmeni (lunsotogene parvec-cwha) in Genetic Hearing Loss

Shots: Otarmeni was approved under CNPV for pediatric & adult pts with sev. to profound and profound sensorineural hearing loss due to biallelic OTOF gene variants, with preserved outer hair cell function & no prior cochlear implant. It will be provided free of charge in the US by Regeneron Approval was based on the P-I/II…

ByRidhi RastogiApril 24, 2026

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Novo Nordisk Reports the P-IIIa (PIONEER TEENS) Trial on Oral Semaglutide for Paediatric Patients with Type 2 Diabetes

Shots: Novo Nordisk has reported the P-IIIa (PIONEER TEENS) trial assessing oral semaglutide (3, 7 or 14mg, QD) vs PBO, on top of background treatment with metformin, basal insulin, or both, in 132 pts (10-17yrs.) with type 2 diabetes Trial showed superior HbA1c reduction vs PBO, lowering blood sugar by 0.83% at 26wks., with a…

ByRidhi RastogiApril 23, 2026

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DemeRx Reports the US FDA IND Application Acceptance to Advance DMX-1001 for Alcohol Use Disorder

Shots: The US FDA has accepted IND application of DMX-1001 (oral noribogaine) for the treatment of alcohol use disorder (AUD) DemeRx completed a MAD trial of DMX-1001 in healthy volunteers, demonstrating safety, tolerability, & PK supportive of P-II in AUD. The company plans to initiate a P-II trial of DMX-1001 in AUD in 2027 Noribogaine…

ByRidhi RastogiApril 23, 2026

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Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Shots: FDA has approved Dupixent to treat CSU pts (age 2-11yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program, & P-III (CUPIDKids) trial Study A & C assessed Dupixent + SoC antihistamines (loading dose then 300mg Q2W; pts weighing <60kg received 200mg) vs PBO…

ByRidhi RastogiApril 23, 2026

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Merck Partners with Google Cloud in ~$1B Deal to Build AI-Enabled Enterprise Platform

Shots: Merck partnered with Google Cloud in a multi-year deal worth up to $1B to deploy an AI-driven agentic platform across R&D, manufacturing, commercial, and corporate functions The collaboration will integrate advanced AI tools, incl. Gemini Enterprise, to enhance productivity, digitize data, & support Merck’s global workforce of ~75,000 employees The partnership aims to accelerate…

ByRidhi RastogiApril 23, 2026

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AstraZeneca Reports the P-III (I CAN) Trial Data on Ultomiris for IgA Nephropathy

Shots: AstraZeneca has reported the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with IgAN who are at risk of disease progression Trial met its 1EP of reduced proteinuria based on 24-hr. UPCR at 34wks., with effect seen as early as 10wks., while the 1EP of change in eGFR will be…

ByRidhi RastogiApril 23, 2026

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Utepreva Launches Utepreva Endometrial Sampler to Support Early Diagnosis of Endometrial Cancer

Shots: Utepreva has launched the Utepreva Endometrial Sampler, a single-use device designed to improve tissue capture & enable early diagnostic evaluation of endometrial cancer, with availability expected in Oct 2026 The device combines three mechanisms for single-pass sampling: a sponge tip absorbs tissue & fluid, a plunger-driven suction aspirates cells & prevents loss, & the…

ByRidhi RastogiApril 23, 2026

Ridhi Rastogi

Mabwell Initiates P-III Trial for 9MW2821 in TNBC

FLEX Vascular Presents 12-month Real-World Data for FLEX Vessel Prep System at CX Symposium 2026

Johnson & Johnson Reports Clinical Findings on Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG) at AAN 2026

Regeneron Reports the US FDA Accelerated Approval of Otarmeni (lunsotogene parvec-cwha) in Genetic Hearing Loss

Novo Nordisk Reports the P-IIIa (PIONEER TEENS) Trial on Oral Semaglutide for Paediatric Patients with Type 2 Diabetes

DemeRx Reports the US FDA IND Application Acceptance to Advance DMX-1001 for Alcohol Use Disorder

Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Merck Partners with Google Cloud in ~$1B Deal to Build AI-Enabled Enterprise Platform

AstraZeneca Reports the P-III (I CAN) Trial Data on Ultomiris for IgA Nephropathy

Utepreva Launches Utepreva Endometrial Sampler to Support Early Diagnosis of Endometrial Cancer

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