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Elanco
NEWS

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

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Eli lilly
NEWS

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

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NEWS

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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Merck new
NEWS

Merck Reports P-III (KEYNOTE-B15) Trial Finding on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The P-III (KEYNOTE-B15/EV-304) trial assessed 4 cycles of Keytruda (IV) + Padcev (IV), followed by surgery & then Keytruda (IV, 13 cycles) plus Padcev (IV, 5 cycles) vs neoadj. SoC + surgery in cisplatin-eligible MIBC pts (n=808) Trial showed that perioperative combination of Keytruda + Padcev significantly improved EFS, OS & pCR rates vs…
December 18, 2025

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NEWS

SleepRes’ Kricket PAP Device Receives the US FDA 510(k) Clearance for Obstructive Sleep Apnea

Shots: The US FDA has granted 510(k) clearance to the Kricket PAP device, powered by Kairos Positive Airway Pressure (KPAP), for the treatment of OSA pts (>66lbs) Kricket PAP device uses KPAP tech to dynamically adjust pressure with each breath, synchronizing with pts’ natural respiration to reduce unnecessary pressure, improve comfort & tolerance, & offering…
December 18, 2025

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Celltrion
NEWS

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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NEWS

Kyverna Therapeutics Reports Topline P-II (KYSA-8) Trial Data of Miv-cel in Stiff Person Syndrome (SPS)

Shots: Kyverna has reported P-II (KYSA-8) trial data assessing a single dose of mivocabtagene autoleucel (miv-cel; KYV-101) in 26 SPS pts having an inadequate response with non-approved treatment options Trial met its 1EP with 46% median improvement in T25FW & 81% pts achieving a clinically meaningful ≥20% gain, plus significant benefits were seen across all…
December 17, 2025

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