Bayer expands MRXperion power injector capabilities with FDA nod

The system also introduces Imaging Scanner Interface 2 (ISI2) capability, enabling direct communication between injector and scanner to improve exam coordination and operational efficiency

Glenmark bags FDA nod for generic asthma inhaler with 180-day exclusivity

FDA nod to YUVIWEL, first once-weekly treatment for kids with achondroplasia

Achondroplasia, a rare genetic disorder, causes skeletal dysplasia and often increases the risk of muscular, neurological, and cardiorespiratory complications

FDA nod to Boehringer Ingelheim’s first-line therapy for HER2-mutant lung cancer

Zongertinib is setting a new standard as the first targeted therapy for treatment naïve patients with HER2-mutant advanced non-small cell lung cancer with demonstrated efficacy

Pfizer bags rull FDA nod for BRAFTOVI combination in aggressive colorectal cancer

BRAFTOVI in combination with cetuximab and mFOLFOX6 had previously received accelerated approval in December 2024 based on objective response rate (ORR) results

Merck Animal Health gets FDA nod for groundbreaking dog allergy drug NUMELVI

CStone Pharmaceuticals’ Sugemalimab bags UK nods for Stage III NSCLC

Sugemalimab, developed using CStone’s OmniRat transgenic platform, is a fully human IgG4 monoclonal antibody designed to minimize immunogenicity and toxicity

UK nod to first-ever drug specifically for non-cystic fibrosis bronchiectasis

NCFB is a chronic lung condition where damaged airways cause persistent coughing and mucus production

FDA nod to AstraZeneca’s all-oral, fixed-duration therapy for CLL & SLL

The decision follows compelling data from the AMPLIFY Phase III trial, demonstrating that 77% of patients receiving the Calquence-venetoclax combination were progression-free at three years

Johnson & Johnson bags FDA nod for monthly RYBREVANT FASPRO dosing in advanced lung cancer

This approval builds on the recent transformation RYBREVANT FASPRO brought to lung cancer care