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NEWS

Hope Medicine’s HMI-115 Receives the US FDA Fast Track Designation for Endometriosis-Associated Pain Relief

Shots: The US FDA has granted FTD to HMI-115 for the treatment of mod. to sev. pain associated with endometriosis Designation was based on the global P-II dose-finding study assessing HMI-115 vs PBO for 12wks. in 108 females with surgically diagnosed endometriosis across the US, Poland & China, showing significant improvement Trial showed that HMI-115…
2 days ago

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Eli lilly
NEWS

Eli Lilly’s Jaypirca Receives the FDA Approval for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Shots: The US FDA has approved label expansion of Jaypirca (pirtobrutinib; 100 & 50mg) for the treatment of adults with r/r CLL/SLL who were previously treated with a covalent BTK inhibitor & converted the accelerated approval of Dec 2023 to a full approval Label expansion was based on the P-III (BRUIN CLL-321) study assessing Jaypirca…
3 days ago

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Innovent
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Innovent Biologics Reports the Chinese NMPA Approval of Pecondle (Picankibart) to Treat Plaque Psoriasis

Shots: The Chinese NMPA has approved Pecondle (picankibart) for the treatment of mod. to sev. plaque psoriasis (PsO) in adults who are candidates for systematic therapy Approval was supported by the P-III (CLEAR-1) trial in Chinese pts with mod. to sev. PsO, where picankibart demonstrated significantly higher PASI 90 (1EP; 80.3% vs 2%) & sPGA 0/1…
November 28, 2025

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Eisai and Biogen Report EU Launch of Leqembi (Lecanemab) to Treat Alzheimer’s Disease
NEWS

Eisai and Biogen Seek Japanese PMDA Approval for Leqembi SC (Lecanemab) to Treat Early Alzheimer’s Disease

Shots: The Japanese PMDA has received NDA for Leqembi SC autoinjector to treat adults with early Alzheimer’s disease (AD) NDA is supported by sub-studies from the P-III (Clarity AD) OLE study in pts with mild cognitive impairment due to AD or mild AD dementia, showing that Leqembi (500mg, SC: two 250mg injections) administered QW, provided exposure equivalent to Q2W IV…
November 28, 2025

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NEWS

Cothera Bioscience’s Zotiraciclib Receives the US FDA Fast Track Designation for Recurrent IDH-Mutated High-Grade Glioma

Shots: The US FDA has granted FTD to zotiraciclib (ZTR/TG02) for the treatment of pts with recurrent high-grade gliomas (rHGG) harboring IDH1 or IDH2 mutations (IDHmut rHGG) Designation was backed by the completion of the P-I trial of zotiraciclib, showing preliminary efficacy & favorable safety as a monotx. in IDHmut rHGG pts, which was presented at…
November 27, 2025

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Novo-Nordisk
NEWS

Novo Nordisk Reports the US FDA’s sNDA Submission for Higher Wegovy Dose for Weight Management

Shots: The US FDA has received an sNDA for a higher dose of Wegovy (7.2mg semaglutide) along with lifestyle intervention for chronic weight management in adults with obesity, with sNDA to be reviewed under CNPV program sNDA was supported by 72wk. STEP UP trial assessing Wegovy (7.2mg, QW) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 obese…
November 27, 2025

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