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Results For "Breakthrough-Therapy"

95 News Found

Otsuka Pharma to acquire Transcend Therapeutics in $1.225 billion deal
News | March 28, 2026

Otsuka Pharma to acquire Transcend Therapeutics in $1.225 billion deal

Otsuka will pay $700 million to Transcend shareholders at closing, with an additional $525 million in contingent payments tied to future sales milestones


FDA grants priority review to Enhertu for high-risk HER2-positive breast cancer
News | March 10, 2026

FDA grants priority review to Enhertu for high-risk HER2-positive breast cancer

Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population


Iza-bren delivers dual survival win in phase III trial for hard-to-treat breast cancer
Clinical Trials | March 02, 2026

Iza-bren delivers dual survival win in phase III trial for hard-to-treat breast cancer

Iza-bren met both dual primary endpoints, delivering statistically significant and clinically meaningful improvements in progression-free survival


FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma
Drug Approval | February 17, 2026

FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma

Iberdomide has the potential to be the first approved CELMoD agent


Pfizer’s HYMPAVZI bags FDA priority review, targeting younger & hard-to-treat hemophilia patients
Drug Approval | February 07, 2026

Pfizer’s HYMPAVZI bags FDA priority review, targeting younger & hard-to-treat hemophilia patients

HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors


FDA go ahead for Eli Lilly’s therapy for hard-to-treat ovarian cancer
Drug Approval | January 21, 2026

FDA go ahead for Eli Lilly’s therapy for hard-to-treat ovarian cancer

Sofetabart mipitecan is a novel folate receptor alpha (FR?) antibody-drug conjugate (ADC) leveraging proprietary linker technology and an exatecan payload to target tumor cells


Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer
Drug Approval | January 08, 2026

Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations


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


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


FDA setback for Sanofi’s Tolebrutinib in progressive MS
Drug Approval | December 27, 2025

FDA setback for Sanofi’s Tolebrutinib in progressive MS

Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity