US FDA approves Otsuka's drug for a type of kidney disease

The U.S. Food and Drug Administration has approved Otsuka's injectable drug to treat patients with a potentially ...
NPR

FDA approves another generic abortion pill, prompting outrage from conservatives

WASHINGTON — Federal officials have approved another generic version of the abortion pill mifepristone, a regulatory formality that quickly triggered pushback from anti-abortion groups and politicians ...
JD Supra

FDA Leaders Propose New “Plausible Mechanism Pathway” for Development and Approval of Drugs and Biologics

The Food and Drug Administration (FDA) has issued a statement, published electronically in the New England Journal of ...
Forbes

A High-Probability FDA-Approval Candidate For October

Amgen (AMGN) and AstraZeneca (AZN) are approaching a potential catalyst event on October 19, when the FDA will rule on Tezspire for treating chronic rhinosinusitis with nasal polyps (CRSwNP). If ...
USA Today

First Study Site Established for Jaguar Health Study of its FDA Conditionally Approved Canalevia-CA1 Prescription Drug for Dogs

Two parallel goals for Canalevia-CA1 (crofelemer delayed-release tablets): To obtain full approval of the drug for treatment of chemotherapy-induced diarrhea (CID) and to expand the indication of ...
MedCity News

On Heels of FDA Nod, BridgeBio’s Rival to Blockbuster Pfizer Drug Wins European Approval

BridgeBio Pharma has received European approval for a drug that treats cardiomyopathy stemming from a rare metabolic condition, strengthening the biotech’s position to take market share from the ...
KETV Omaha

FDA approves another generic abortion pill

Federal officials have approved another generic version of the abortion pill mifepristone, a regulatory formality that quickly triggered pushback from anti-abortion groups and politicians aligned with ...