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Boehringer Ingelheim
NEWS

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for 1L HER2-Mutant NSCLC

Shots: The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the 1L treatment of pts with advanced NSCLC harboring HER2 (ERBB2) tyrosine kinase domain activating mutations Approval was based on the data from a treatment-naïve cohort (N=72) of the P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 76% (11%…
February 27, 2026

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NEWS

Boehringer Ingelheim Inks $500M+ Deal with Sitryx Therapeutics for Novel Oral Immune Disease Therapies

Shots: Sitryx Therapeutics has granted BI an exclusive license to a preclinical, small molecule program, offering a disease-modifying treatment approach across multiple autoimmune & inflammatory disease indications As per the deal, BI will receive an exclusive global license to the multiple assets & related IP to the small molecule inhibitor program, plus it will assume…
February 27, 2026

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NEWS

Cara Medical Reports 510(k) clearance of CARA System for Noninvasive Cardiac Conduction System Visualization

Shots: The US FDA has granted 510(k) clearance to CARA System for non-invasive, patient-specific 3D visualization of the cardiac conduction system, with commercialization to begin in the coming mos. The CARA System combines the CARA MetisTM Simulator, a preprocedural CTA-based simulator to create a personalized 3D map of the cardiac conduction system, with the CARA…
February 26, 2026

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Merck Animal Health
NEWS

Merck Animal Health’s Numelvi Secures the FDA Approval for Control of Pruritus Associated with Allergic Dermatitis in Dogs

Shots: The US FDA has approved Numelvi (Atinvicitinib) for the control of pruritus associated with allergic dermatitis in dogs (≥6mos.), with availability expected in spring 2026 Numelvi is a second-generation JAK inhibitor supplied in easy-to-dispense bottles and designed for convenient storage under standard conditions. Numelvi is ≥10-fold more selective for JAK1 over JAK2, JAK3 &…
February 26, 2026

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NEWS

Novo Nordisk and Vivtex Partner in ~2.1B Metabolic Deal to Develop Oral Therapies

Shots: Novo Nordisk has partnered with Vivtex to develop next-generation oral biologics for obesity, diabetes, & related comorbidities, leveraging Vivtex’s GI screening & formulation platform Vivtex will license select oral drug-delivery techs to Novo, which will lead global development, regulatory, manufacturing & commercialization, while Vivtex will receive an upfront, research funding, & milestone payments totalling…
February 26, 2026

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Pfizer New
NEWS

Pfizer’s Braftovi Regimen Receives US FDA Full Approval for Metastatic Colorectal Cancer

Shots: The US FDA has granted full approval to Braftovi + cetuximab & fluorouracil-based CT for the treatment of adults with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation Approval was backed by the P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in pts, randomized to Braftovi + cetuximab (n=158), Braftovi + cetuximab + mFOLFOX6 (n=236),…
February 25, 2026

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