breakthrough therapy news

GSK's ADC Drug Gets FDA's Breakthrough Tag for Rare Bone Cancer

GSK plc GSK announced that the FDA has granted a Breakthrough Therapy Designation to its investigational B7-H3-targeted antibody-drug conjugate (ADC), GSK5764227 (GSK’227), for the treatment of relapsed or refractory osteosarcoma in adult patients whose disease progressed on at least two prior lines of therapy.

Business Insider · 2d

FDA Grants Breakthrough Therapy Designation To GSK's GSK5764227 For Bone Cancer

GSK plc (GSK, GSK.L) said that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for GSK5764227, its

조선일보 · 1d

Korea's Resolute gains FDA breakthrough therapy designation for RZ358 treatment

Koreas Resolute gains FDA breakthrough therapy designation for RZ358 treatment Resolute receives FDA recognition for innovative hypoglycemia treatment RZ358

The Financial Times · 1d

GSK nears $1bn deal for biotech developing drug for rare tumour

GSK is nearing a $1bn deal to buy a US biotech developing a treatment for rare gastrointestinal tumours, as the UK drugmaker races to expand its oncology business. The UK group is in advanced talks to buy privately owned biotech IDRx,

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FDA awards GSK breakthrough status for relapsed osteosarcoma treatment

"FDA awards GSK breakthrough status for relapsed osteosarcoma treatment" was originally created and published by ...

Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism

Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital ...

Cancer Therapy Advisor1d

Novel Antibody-Drug Conjugate Gets Breakthrough Tx Designation for Rel/Ref Osteosarcoma

GSK5764227 (HS-20093) is a novel antibody-drug conjugate composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload.

Targeted Oncology1d

FDA Grants B7-H3–Targeted ADC Breakthrough Status in Osteosarcoma

The FDA’s breakthrough therapy designation for GSK’227 underscores its potential to address the critical unmet needs of ...

Mabwell's Nectin-4 Targeted ADC 9MW2821 Combination Therapy Demonstrates 87.5% ORR and Granted CDE Breakthrough Therapy Designation

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced a significant milestone for its proprietary Nectin-4 targeted ADC (9MW2821). On January 8, 2025, ...

Colorado can now issue licenses to psychedelic mushroom therapy facilitators

This story first appeared in Colorado Newsline. Coloradans will soon be able to take psychedelic mushrooms in a regulated ...

Sana Biotechnology: Stock Price Rise Deserved Post Diabetes Cell Therapy Success

Sana Biotechnology, Inc. shares surge as a breakthrough in diabetes therapy sparks investor interest. Click for my updated ...

Monthly Prescribing Reference1d

Novel Antibody-Drug Conjugate Gets Breakthrough Tx Designation for R/R Osteosarcoma

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to GSK5764227 (GSK’227) for the treatment of adult patients with relapsed or refractory (R/R) osteosarcoma who have ...

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Breakthrough therapy repairs cartilage damage in under 4 hours

A groundbreaking therapy first introduced by Northwestern University researchers in 2021 has shown promise in regenerating ...

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