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Results For "US-FDA"

423 News Found

Lupin receives EIR from FDA for its Goa facility
Drug Approval | February 28, 2026

Lupin receives EIR from FDA for its Goa facility

The EIR was issued following an inspection of the facility from November 10 to November 21, 2025


FDA nod to Boehringer Ingelheim’s first-line therapy for HER2-mutant lung cancer
Drug Approval | February 28, 2026

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
Drug Approval | February 27, 2026

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


Formosa strikes exclusive deal with Arrotex to launch eye surgery drug in Australia & NZ
News | February 25, 2026

Formosa strikes exclusive deal with Arrotex to launch eye surgery drug in Australia & NZ

The innovative eyedrop targets inflammation and pain following ocular surgery


Novo Nordisk unveils weight-loss data from REDEFINE 4 trial
Clinical Trials | February 25, 2026

Novo Nordisk unveils weight-loss data from REDEFINE 4 trial

CagriSema produced a 23% weight loss at 84 weeks, versus 25.5% for tirzepatide


FDA approves Lilly's Zepbound multi-dose KwikPen for obesity treatment
Drug Approval | February 24, 2026

FDA approves Lilly's Zepbound multi-dose KwikPen for obesity treatment

In 2025, over 1 million patients accessed Lilly treatments through LillyDirect


Ultragenyx bags FDA priority review for groundbreaking GSDIa gene therapy
Drug Approval | February 24, 2026

Ultragenyx bags FDA priority review for groundbreaking GSDIa gene therapy

If approved, DTX401 would be the first treatment to address the disease at its root cause


FDA nod to AstraZeneca’s all-oral, fixed-duration therapy for CLL & SLL
Drug Approval | February 23, 2026

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


FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer
Drug Approval | February 21, 2026

FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer

The NDA filing is supported by results from the phase III evERA Breast Cancer study