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Daiichi Sankyo
Daiichi Sankyo Reports the EMA’s MAA Validation of Datroway to Treat Metastatic Triple Negative Breast Cancer
Shots: The EMA has validated the Type II Variation MAA for Daiichi's Datroway (datopotamab deruxtecan) as monotx. For the 1L treatment of adults with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy; additional regulatory filings are underway MAA was supported by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644…
December 19, 2025
Shanghai Henlius Receives the US FDA IND Clearance for HLX18 (Biosimilar, Opdivo)  
Shots:  The US FDA has granted IND clearance to HLX18 (nivolumab), a biosimilar version of Opdivo, for the treatment of certain resected solid tumors   Novolumab is an mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma   HLX17 (pembrolizumab biosimilar) and HLX13 (ipilimumab biosimilar) have entered worldwide multicenter P-I…
December 19, 2025
Abbott
Abbott Reports FDA Clearance and CE Mark Approval of its Amplatzer Piccolo Delivery System for Premature Babies with a Hole in the Heart
Shots: Abbott has received the US FDA clearance & European CE Mark for its Amplatzer Piccolo Delivery System, used with Amplatzer Piccolo Occluder, to treat premature babies (≥2lbs) with patent ductus arteriosus (PDA; hole in the heart) Approved in the US & EU in 2019, Amplatzer Piccolo Occluder is a minimally invasive transcatheter device, smaller…
December 19, 2025
Elanco
Elanco’s Credelio Quattro-CA1 Receives the FDA’s Conditional Approval to Treat New World Screwworm Infestations in Dogs
Shots: The US FDA has granted conditional approval to Elanco's Credelio Quattro-CA1 (lotilaner, moxidectin, praziquantel, & pyrantel) for the treatment of infestations caused by New World screwworm larvae (myiasis) in dogs Approval was based on a study showing that oral lotilaner achieved 100% efficacy against New World screwworm (Cochliomyia hominivorax) larvae within 24hrs. at the…
December 19, 2025
Eli lilly
Eli Lilly Reports Topline P-III (ATTAIN-MAINTAIN) Trial Results of Orforglipron for Weight Loss Maintenance 
Shots: Lilly's P-III trial assessed orforglipron vs PBO in maintaining weight loss in 376 adults with obesity/overweight & weight-related comorbidities who previously completed the initial treatment with Wegovy/Zepbound in the SURMOUNT-5 trial; NDA was submitted to FDA & received a US FDA’s CNPV Trial met its 1EP in SURMOUNT-5 pts at a weight plateau, showing superior…
December 19, 2025
Johnson & Johnson Receives the US FDA Approval for Rybrevant Faspro to Treat EGFR-Mutated NSCLC
Shots: FDA has approved J&J’s Rybrevant Faspro (amivantamab & hyaluronidase-lpuj, SC) for the treatment of pts with EGFRm NSCLC, covering all approved indications of Rybrevant Approval was backed by P-III (PALOMA-3) trial, evaluating SC vs IV RoA of Rybrevant, in combination with Lazcluze in advanced or metastatic EGFRm NSCLC pts (n=418) whose disease progressed on Tagrisso & Pt-based…
December 18, 2025
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