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News about "Breakthrough Therapy Designation "
Merck Wins US FDA Breakthrough Therapy Designation Status for Enpatoran in Lupus
Merck has received US Food and Drug Administration (FDA) Breakthrough Therapy Designation (BTD) for enpatoran in lupus patients with active skin manifestations, advancing a potential first approved treatment for cutaneous lupus.
Breakthrough Therapy Designation | 09/07/2026 | By News Bureau
INTENT Biologics Secures FDA Breakthrough Therapy Tag for Diabetic Foot Ulcer Treatment Candidate
INTENT Biologics' PEP Biologic receives FDA Breakthrough Therapy designation for diabetic foot ulcers, accelerating development of its first-in-class exosome-based regenerative treatment aimed at improving healing outcomes in chronic wounds.
Breakthrough Therapy Designation | 03/07/2026 | By News Bureau | 188
Incyte to Acquire Vega Therapeutics, Expanding Hematology Portfolio
Incyte has agreed to acquire Vega Therapeutics, expanding its hematology portfolio into bleeding disorders with the addition of VGA039, a phase 3 investigational monoclonal antibody for von Willebrand disease. The deal includes USD 1.25 billion upfront and up to USD 750 million in additional payments upon achievement of sales milestones.
Breakthrough Therapy Designation | 09/06/2026 | By News Bureau
Partner Therapeutics Wins FDA Approval for BIZENGRI in NRG1+ Cholangiocarcinoma
Partner Therapeutics receives US Food and Drug Administration (FDA) approval for BIZENGRI, the first targeted therapy for NRG1 fusion-positive cholangiocarcinoma, expanding use across NSCLC and pancreatic cancer.
Breakthrough Therapy Designation | 12/05/2026 | By News Bureau
Bayer Reports Positive Phase 3 Results for Investigational Cardiac Amyloidosis Imaging Agent
REVEAL study demonstrates strong diagnostic sensitivity and specificity of I 124 evuzamitide PET/CT radiotracer for detecting cardiac amyloidosis, supporting plans for regulatory discussions with the FDA.
Breakthrough Therapy Designation | 08/05/2026 | By News Bureau | 143
U.S. Food and Drug Administration grants Priority Review and Breakthrough Therapy status to combination therapy showing significant survival benefits in advanced HER2-positive gastric and esophageal cancers.
Breakthrough Therapy Designation | 01/05/2026 | By News Bureau
Hope Medicine Reports Positive Phase II Results for First-in-Class Endometriosis Drug
HMI-115 shows significant pain reduction without hormonal disruption, paving the way for global phase III trials.
Breakthrough Therapy Designation | 26/03/2026 | By News Bureau | 233
US Food and Drug Administration grants Priority Review to supplemental application for Enhertu to treat HER2-positive breast cancer patients with residual disease after neoadjuvant therapy, with decision expected in Q3 2026.
Breakthrough Therapy Designation | 10/03/2026 | By News Bureau | 144
Japan's MHLW accepts GSK's Bepirovisen for Review to Treat Chronic Hepatitis B
Japan’s health ministry has accepted GSK’s new drug application for investigational antisense therapy bepirovirsen, after Phase III trials showed significantly higher functional cure rates in chronic hepatitis B patients.
Breakthrough Therapy Designation | 27/02/2026 | By News Bureau | 617
Iberdomide, an investigational oral CELMoD therapy, is under FDA review in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma.
Breakthrough Therapy Designation | 19/02/2026 | By News Bureau | 160
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