KSAT

Women celebrate FDA removal of black box warning on hormone replacement therapy products

For decades, hormone replacement therapies carried warnings that they increased the risk of cancer and dementia. Now, that ...

US FDA adds strongest warning to Sarepta's Elevidys after fatal liver injuries

The U.S. Food and Drug Administration said on Friday it approved new labeling for Sarepta Therapeutics' gene therapy Elevidys ...
BioSpace

FDA Imposes Boxed Warning, Narrows Patient Pool for Sarepta’s Duchenne Gene Therapy Elevidys

Sarepta must also run a post-marketing study for Elevidys to better assess the risk of serious liver injury in patients dosed ...
Stocktwits on MSN

Sarepta Stock Slides Premarket After New FDA Warning Shrinks Market For Its $3.2M DMD Gene Therapy

FDA added a boxed warning to Elevidys after two pediatric deaths and imposed stricter monitoring rules. ・Use of gene therapy ...
STAT

FDA’s stronger warning on Sarepta gene therapy raises new questions about heart risk

Risk of “acute, serious, and life-threatening” heart inflammation is now on the label of Sarepta's gene therapy for Duchenne ...

FDA removes the black box warning on hormone therapy for menopause

Hormone therapy helps women. Now the FDA is reversing its warning on estrogen treatment which could change treatemtn for ...

The FDA removes a long-standing warning from hormone-based menopause drugs

The Food and Drug Administration says it will remove a long-standing warning from hormone-based drugs used to treat menopause ...
USC Center for Health Journalism

Despite FDA warnings, this ‘natural remedy’ remains popular among S.F. immigrants

In San Francisco, a growing number of Latinos who work physically demanding jobs are turning to supplements like Artri Ajo ...

FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths

The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year.

I went through the wringer to get menopause drugs — what we need as FDA changes ‘black box’ warning

The FDA recently announced it would remove “misleading” black box warnings for drugs that use hormones to treat menopause.

Sarepta’s Elevidys to Remain on Market With New FDA Warning

Sarepta Therapeutics Inc.’s controversial gene therapy for a rare muscle condition will remain available in the US with a ...

FDA moves to lift ‘black box’ warnings from hormone therapies for menopause symptoms

FDA seeks to lift “black box" warnings from menopause hormone therapy, citing evidence that benefits outweigh risks.