MPR

Trastuzumab Deruxtecan Gets Priority Review for High-Risk HER2+ Early Breast Cancer

Data show T-DXd improves invasive disease-free survival and reduces the risk of distant recurrence in early HER2-positive breast cancer.
CURE

FDA Grants Priority Review to Enhertu for HER2-Positive Breast Cancer

FDA Priority Review was granted for trastuzumab deruxtecan in post-neoadjuvant HER2-positive early breast cancer with residual invasive disease, with a regulatory decision anticipated in Q3 2026.
Yahoo Finance

Ultragenyx Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application (BLA) for DTX401 AAV Gene Therapy for Glycogen Storage Disease Type Ia (GSDIa)

NOVATO, Calif., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced the U.S. Food and Drug Administration (FDA or the Agency) has accepted for review the ...
Electronics Weekly

Mouser signs ic-Haus

Among ic-Haus products are: The iC-PZ2656 a high-resolution reflective absolute encoder is a complete lensless optical reflective absolute encoder IC. With its integrated blue LED and interpolator, ...
Fierce Pharma

Boehringer's Hernexeos secures speedy first-line expansion in FDA's 2nd national priority nod

The nod allows Hernexeos (zongertinib) to be used as an initial treatment option for NSCLC with HER2-activating mutations in ...
BioSpace

Boehringer Wins Speedy Lung Cancer Approval Under Commissioner’s Priority Program

Hernexeos is the second drug to secure an FDA approval under the agency’s priority voucher scheme, following in the footsteps of USAntibiotics’ Augmentin XR, which was granted the ticket in December ...
Yahoo Finance

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for ...

OSAKA, Japan & CAMBRIDGE, Mass., February 10, 2026--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) ...

The 12 Research Papers That Influenced AI Development Over The Last 6 Years

Over the past six years, artificial intelligence has been significantly influenced by 12 foundational research papers. One ...
AFP

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for ...

Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the ...
PharmiWeb

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for ...

This FDA Acceptance is a Milestone for People Living with Narcolepsy Type 1 Who Need New and Different Treatment Options Oveporexton is an Orexin Agonist Designed to Restore Orexin Signaling and ...
Business Wire

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for ...

NT1 is a chronic, rare neurological disease caused by a loss of orexin and characterized by excessive daytime sleepiness and cataplexy (sudden loss of muscle tone). This results in a spectrum of ...