CURE

FDA Grants Breakthrough Therapy Designations to AbbVie's Temab-A in Colorectal and Lung Cancers

The FDA has granted two Breakthrough Therapy Designations to telisotuzumab adizutecan (Temab-A, also known as ABBV-400), an ...
Medical Xpress

Can gene therapy provide a breakthrough in Alzheimer's disease?

Therapeutic gene transfer to specific brain regions in animal models of Alzheimer's disease has uncovered multiple potential treatment approaches that deserve to be considered as candidates for ...
Forbes

FDA Grants Breakthrough Therapy Status To LSD Drug To Treat Anxiety

The U.S. Food and Drug Administration last week granted “breakthrough therapy” status to a form of the psychedelic drug LSD as a treatment for anxiety. The drug, a form of LSD (lysergide d-tartrate) ...

AbbVie's Telisotuzumab Adizutecan (Temab-A) Receives Two Breakthrough Therapy Designations From the U.S. FDA for CRC and NSCLC

AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted two Breakthrough Therapy Designations (BTDs) for telisotuzumab adizutecan (Temab-A; ABBV-400) in ...
BioSpace

Legacy Healthcare’s CINAINU® Receives FDA Breakthrough Therapy Designation for Alopecia Areata in Adults, Adolescents and Children Aged 2 Years and Older

Legacy Healthcare, a biopharmaceutical company developing innovative botanical prescription drugs, today announced that the U ...
Yahoo Finance

Neurogene Announces FDA Breakthrough Therapy Designation for NGN-401 Gene Therapy for Rett Syndrome

NEW YORK, February 26, 2026--(BUSINESS WIRE)--Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic medicines to patients and families affected by rare ...
Nasdaq

Orchestra BioMed Receives FDA Breakthrough Device Designation for Atrioventricular Interval Modulation Therapy to Address Uncontrolled Hypertension

Orchestra BioMed has announced that the FDA has granted Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy, aimed at treating over 7.7 million U.S. patients ...
Medical Xpress

Gene therapy trial offers breakthrough for rare genetic disorder

A study evaluating a pioneering lentivirus (LV)-mediated gene therapy trial for classical Fabry disease showed promising results over five years, indicating a potential breakthrough in treatment for ...
Cure Today

Enhertu Gets Breakthrough Therapy Designation for HER2-Low/Ultralow Breast Cancer

The FDA will speed up their review of Enhertu for HR-positive, HER2-low/ultralow advanced breast cancer that cannot be removed via surgery. The Food and Drug Administration (FDA) granted a ...
Yahoo

FDA grants breakthrough therapy designation to Lilly’s olomorasib

Add Yahoo as a preferred source to see more of our stories on Google. Olomorasib is an investigational inhibitor targeting the KRAS G12C protein The US Food and Drug Administration (FDA) has granted ...
MarketScreener

AbbVie Receives Two Breakthrough Therapy Designations From The U.S. FDA For Telisotuzumab Adizutecan In Colorectal Cancer And Non-Small Cell Lung Cancer

AbbVie announced that the U.S. Food and Drug Administration (FDA) has granted two Breakthrough Therapy Designations (BTDs) for telisotuzumab adizutecan (Temab-A; ABBV-400) in colorectal cancer (CRC) ...

Gene therapy: The breakthrough that inspired Spider-Man | Euronews Tech Talks

Although an inspiration for science fiction movies, gene therapy is real. Here is how it works and what could be improved about it. View on euronews ...