Top Republican eyeing FDA overhaul

Sen. Bill Cassidy (R-La.) on Tuesday unveiled his proposal for modernizing the Food and Drug Administration (FDA), calling on ...

Disc Medicine EPP Treatment Fails to Get FDA Accelerated Approval

Disc Medicine received a complete response letter from the Food and Drug Administration denying it accelerated approval of its bitopertin treatment for erythropoietic protoporphyria, a metabolic ...
Yahoo

Legal questions swirl around FDA's new expedited drug program, including who should sign off

WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...
Nasdaq

Cytokinetics Wins FDA Approval for Cardiovascular Drug, Stock up

Cytokinetics, Incorporated CYTK announced that the FDA approved its lead pipeline candidate, aficamten, for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to ...
Yahoo

With FDA approval of Wegovy pill, new era of oral GLP-1 weight loss drugs begins

Add Yahoo as a preferred source to see more of our stories on Google. The FDA has approved a new pill version of the weight-loss drug Wegovy - Novo Nordisk The US Food and Drug Administration on ...
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 ...
WebMD

FDA Approves Nuzolvence: A First-in-Class, Single-Dose Oral Antibiotic for Drug-Resistant Gonorrhea

What Is Nuzolvence, and Why Does It Matter? Nuzolvence (zoliflodacin) is a new oral antibiotic approved by the FDA to treat uncomplicated gonorrhea of the urinary and genital tract. It is meant for ...