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News about "Breakthrough Therapy Designation "
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 | 120
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
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 | 378
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 | 108
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 | 117
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 | 133
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 | 206
Immix Biopharma Gets US FDA Breakthrough Therapy Designation for NXC-201
Immix Biopharma has received US FDA Breakthrough Therapy Designation for its CAR-T candidate NXC-201, based on positive interim phase-II results from the NEXICART-2 study presented at the ASH 2025 annual meeting, with final data expected later this year followed by a planned Biologics Licence Application (BLA) submission.
Breakthrough Therapy Designation | 29/01/2026 | By News Bureau | 124
Bayer Secures Breakthrough Status for Sevabertinib in HER2 NSCLC
US FDA and China’s CDE granted the designation for sevabertinib as a potential first-line therapy in advanced HER2-mutant non-small cell lung cancer.
Breakthrough Therapy Designation | 07/01/2026 | By News Bureau | 255
Akeso's Ivonescimab Wins 4th Breakthrough Therapy Nod in China for TNBC
Akeso has secured its fourth Breakthrough Therapy Designation (BTD) in China for Ivonescimab, targeting first-line treatment of triple-negative breast cancer (TNBC). The ongoing Phase III HARMONi-BC1 trial is assessing its safety and efficacy in this hard-to-treat cancer type.
Breakthrough Therapy Designation | 03/11/2025 | By Dineshwori | 190
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