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NEWS

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
Celltrion
Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the CHMP Positive Opinion for Multiple Immune-Mediated Diseases
Shots: The CHMP has recommended Celltrion's Steqeyma autoinjector (45mg/0.5mL & 90mg/1mL), a biosimilar version of Stelara (ustekinumab), for the treatment of pts with plaque psoriasis, psoriatic arthritis (PsA) & Crohn’s disease (CD) SteQeyma (CT-P43) is a human anti-IL-12 & IL-23 monoclonal antibody that is also available in SC formulation (45mg/0.5 mL or 90mg/1 mL in…
December 18, 2025
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