Exclusive-US FDA cleared pricey rare disease drug over reviewer objections

The U.S. FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, ...
CIDRAP

FDA approves new IV antibiotic for complicated urinary tract infections

The intravenous formulation of fosfomycin has a novel mechanism of action an no known cross-resistance to other antibiotic ...

'Dilbert' creator's desperate plea shines spotlight on alternative prostate cancer drug

The FDA-approved drug Pluvicto offers hope for advanced prostate cancer patients, but access barriers remain despite proven ...

New menopause drug without hormones approved by FDA. A doctor shares what to know.

The U.S. Food and Drug Administration has approved Lynkuet, a new medication that does not contain hormones to treat hot ...
Neurology Advisor

FDA Drug Approval Decisions Expected in December 2025

Treatments for asthma, chronic rhinosinusitis with nasal polyps, dyslipidemia, Cushing syndrome, gonorrhea, HSCT-associated thrombotic microangiopathy, marginal zone lymphoma, motion sickness, ...

Searching 'weight' can bring up Ozempic in results. It's a drug advertising loophole

There are strict rules about what drug companies can say in TV or print ads. But a new study shows there's a lot more wiggle ...

FDA approves a new drug for hot flashes. Here’s what to know about it.

Elinzanetant belongs to a new class of drugs designed to target what is believed to be a key mechanism responsible for ...

Ironwood wins FDA label expansion for bowel disease drug developed with AbbVie

Ironwood Pharmaceuticals (IRWD) stock gains as the FDA approves a label expansion for the company's AbbVie (ABBV)-partnered ...

FDA approves non-hormonal menopause drug to treat hot flashes, night sweats

The Food and Drug Administration has approved a new non-hormonal pill to treat hot flashes and night sweats brought on by ...

New menopause drug to target hot flashes without hormones gets FDA approval

The US Food and Drug Administration has approved another once-a-day pill that works without hormones to treat moderate to severe hot flashes in menopausal women, drugmaker Bayer said Friday. The drug, ...