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News about "Breakthrough Therapy Designation "
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 | 110
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 | 199
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 | 132
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 | 536
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 | 140
Takeda's Oveporexton NDA Accepted by US FDA with Priority Review for Narcolepsy Type 1
FDA grants Priority Review to Takeda’s investigational orexin receptor agonist oveporexton (TAK-861) for narcolepsy type 1, with a PDUFA decision expected in Q3 this year.
Breakthrough Therapy Designation | 11/02/2026 | By News Bureau | 151
FDA Grants Breakthrough Therapy Designation to Sanofi's Wayrilz for Rare Blood Disorder wAIHA
The US FDA has granted breakthrough therapy designation to Wayrilz (rilzabrutinib) for warm autoimmune haemolytic anaemia, while Japan’s health ministry awarded orphan status, accelerating development for the rare disorder.
Breakthrough Therapy Designation | 11/02/2026 | By News Bureau | 158
Akeso Secures Fifth NMPA Breakthrough Designation for Ivonescimab
The breakthrough designation supports ivonescimab combined with chemotherapy for first-line treatment of advanced Biliary Tract Cancer (BTC), based on an ongoing phase-III study comparing it with durvalumab-based chemotherapy.
Breakthrough Therapy Designation | 07/02/2026 | By News Bureau | 247
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