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Results For "ANDA"

2589 News Found

Merck initiates phase 3 trial of calderasib with Keytruda QLEX for NSCLC
Clinical Trials | January 11, 2026

Merck initiates phase 3 trial of calderasib with Keytruda QLEX for NSCLC

KRAS G12C-mutant advanced or metastatic nonsquamous non-small cell lung cancer


Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR
Drug Approval | January 09, 2026

Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR

This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million


Iksuda reports promising early results for HER2-targeted therapy in oesophageal cancer
Clinical Trials | January 09, 2026

Iksuda reports promising early results for HER2-targeted therapy in oesophageal cancer

The Phase 1 study, a non-randomised, open-label, multicentre trial, is evaluating IKS014 in patients with locally advanced or metastatic solid tumours expressing HER2


Breakthrough in PsA: Taltz plus Zepbound show major gains for patients with obesity
R&D | January 09, 2026

Breakthrough in PsA: Taltz plus Zepbound show major gains for patients with obesity

This is the first controlled pharmacologic study to demonstrate that treatment of obesity improved PsA disease measures


GSK’s Exdensur wins Japanese nod for severe asthma
Drug Approval | January 08, 2026

GSK’s Exdensur wins Japanese nod for severe asthma

The approval follows robust data from the SWIFT and ANCHOR Phase III trials


Alumis reports breakthrough Phase 3 results for oral psoriasis therapy
Clinical Trials | January 08, 2026

Alumis reports breakthrough Phase 3 results for oral psoriasis therapy

The therapy was well tolerated through Week 24, with a safety profile consistent with Alumis’ Phase 2 data


Rapid-acting ADHD treatment Azstarys now approved in China
Drug Approval | January 08, 2026

Rapid-acting ADHD treatment Azstarys now approved in China

ADHD is a common, chronic neurodevelopmental disorder that often begins in childhood and can persist into adulthood


Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy
R&D | January 08, 2026

Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy

The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production