US FDA approves labeling changes to menopause hormone therapies

Feb 12 (Reuters) - The U.S. Food and Drug Administration said on Thursday it has approved labeling changes to six menopause ...
Healio

FDA approves revised hormone therapy black box warning for menopause treatments

The FDA approved changes to the labels for six menopausal hormone therapy products in a move the agency said clarifies risk ...

FDA approves warning removal for 6 hormone-replacement therapies

The new labeling for the products does not include risk statements related to cardiovascular disease, breast cancer and probable dementia, the agency said.
Fierce Biotech

BridgeBio preps approval push after dwarfism drug increases children's height in phase 3

BridgeBio is hoping infigratinib will get another shot at approval after the medicine hit the key goals of a phase 3 study in ...
Fierce Pharma

PTC shuts down FDA approval bid for troubled Duchenne med Translarna

With the writing apparently on the wall, PTC Therapeutics has called off its latest bid for FDA approval of its Duchenne muscular dystrophy (DMD) drug Translarna.  | Late Thursday, PTC revealed that ...
The Cardiology Advisor

FDA Drug Approval Decisions Expected in March 2026

Treatments for acquired hypothalamic obesity, dry eye disease, primary biliary cholangitis, psoriatic arthritis, and severe leukocyte adhesion deficiency-I under review.
Fierce Biotech

Ultragenyx lays off 10% of workforce as FDA continues to stall gene therapy approval plans

Ultragenyx Pharmaceutical's employees were already braced for changes as the biopharma considered how to rebound from a pair ...
Pulmonology Advisor

FDA Alert: Pulmonology Drug Approvals, Recalls, and Device Updates

FDA drug alerts in pulmonology, including drug approvals/warnings, vaccine approvals, medical device recalls/updates, and drug label updates.