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Results For "priority-review"

123 News Found

Merck posts mixed Q1 2026 results as blockbuster drugs drive growth
News | May 02, 2026

Merck posts mixed Q1 2026 results as blockbuster drugs drive growth

But acquisition charges drag earnings into loss


Asahi Kasei seals Aicuris acquisition to bolster infectious disease pharma push
Biopharma | April 22, 2026

Asahi Kasei seals Aicuris acquisition to bolster infectious disease pharma push

The deal the group says marks a decisive push deeper into severe infectious diseases and the build-out of a global specialty pharmaceuticals platform


FDA fast-tracks Daiichi Sankyo & Merck lung cancer drug review
Drug Approval | April 14, 2026

FDA fast-tracks Daiichi Sankyo & Merck lung cancer drug review

The FDA is also reviewing the application under its Real-Time Oncology Review (RTOR) program and Project Orbis


Rocket Pharma gets FDA nod for first pediatric gene therapy targeting severe LAD-I
R&D | March 29, 2026

Rocket Pharma gets FDA nod for first pediatric gene therapy targeting severe LAD-I

The approval covers pediatric patients without a matched sibling donor for stem cell transplant


BeOne Medicines wins first-in-world nod for Sonrotoclax in China
Drug Approval | January 09, 2026

BeOne Medicines wins first-in-world nod for Sonrotoclax in China

The approval is backed by data showing deep, durable responses and manageable tolerability


Wockhardt files marketing authorisation application for WCK 5222 with EMA
News | January 08, 2026

Wockhardt files marketing authorisation application for WCK 5222 with EMA

WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation


Savara resubmits FDA application for potential treatment in rare lung disease patients
Biopharma | January 01, 2026

Savara resubmits FDA application for potential treatment in rare lung disease patients

The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer


SN Bioscience’s SNB-101 wins FDA orphan drug designation for gastric cancer
Clinical Trials | December 29, 2025

SN Bioscience’s SNB-101 wins FDA orphan drug designation for gastric cancer

The drug, currently in a phase 1b/2 clinical trial for small cell lung cancer, is a polymer nanoparticle formulation of SN-38