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, ...

2 killed in U.S. strike on alleged drug boat in Eastern Pacific, Hegseth says

The military strike was at least the 16th strike on a suspected drug boat since President Donald Trump returned to office.
Medpage Today on MSN

FDA Approves IV Antibiotic for Complicated UTIs

The FDA approved an intravenous (IV) formulation of fosfomycin (Contepo) to treat adults with complicated urinary tract ...

Pfizer, Novo Nordisk Escalate Bidding War for Weight-Loss Drug Startup

The deal comes after Pfizer on Monday filed a second lawsuit against Metsera and Novo Nordisk, alleging the weight-loss drug ...

'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 ...

Palvella Therapeutics Announces New QTORIN™ Product Candidate, QTORIN™ Pitavastatin, for the Treatment of Disseminated Superficial Actinic Porokeratosis (DS…

DSAP is a premalignant, progressive disease characterized by numerous expanding lesions which significantly impact quality-of ...
STAT

Compass Pathways expects earlier FDA approval decision on its psilocybin drug

Compass Pathways, which is developing a psilocybin treatment for severe depression, said it now expects an earlier decision ...
PharmExec

FDA Approves Kygevvi Becoming the First Treatment for Thymidine Kinase 2 Deficiency

UCB has announced FDA’s approval of Kygevvi (doxecitine and doxribtimine) for the treatment of adults and pediatric patients ...
Opinion

Don’t let copycat GLP-1 weight loss drugs exploit Pa.'s most vulnerable people | Opinion

Unregulated compounded GLP-1s are not the same as the legitimate medications that doctors prescribe for weight loss and chronic disease management.

Even A Likely FDA Approval For A Rare Disorder May Not Meaningfully Move The Needle For This Biotech Stock

A biotech stock with strong FDA approval odds this November may see limited upside amid a full valuation and a pending lawsuit.
The Manila Times

Immuron IMM-529 IND approved by FDA

Immuron receives U.S. Food and Drug administration (FDA) approval for IMM-529 Investigational New Drug (IND) application and clinical study may proceed FDA assigned an IND number (032095) for the ...