regulatory approval

News

Akebia joins GSK in US market for oral CKD anaemia drugs

The FDA has approved Akebia Therapeutics’ vadadustat as a treatment for anaemia caused by chronic kidney disease (CKD) in dialysis patients, becoming the first rival to GS

News

Japan clears first CLDN18.2 drug, Astellas’ Vyloy

Astellas has become the first drugmaker to bring a claudin 18.2 (CLDN18.2) targeted therapy to regulatory approval, getting a green light in Japan for Vyloy as a treatment

News

MSD leaps on FDA approval of PAH drug sotatercept

MSD’s sotatercept has become the first FDA-approved therapy for pulmonary arterial hypertension (PAH) that addresses the underlying mechanism behind the disease, rather th

News

At second ask, FDA clears AZ’s Ultomiris for NMOSD

AstraZeneca’s Ultomiris has been approved by the FDA to treat rare autoimmune disease neuromyelitis optica spectrum disorder (NMOSD), six months after an earlier applicati

News

FDA okays Italfarmaco’s non-steroidal DMD therapy Duvyzat

Italfarmaco’s oral HDAC inhibitor givinostat has been approved in the US as a treatment for Duchenne muscular dystrophy (DMD), becoming the first non-steroidal option for

News

Idorsia first-in-class hypertension drug gets FDA okay

Idorsia Pharmaceuticals has claimed FDA approval for aprocitentan as a treatment for resistant hypertension, becoming the first drug in the endothelin receptor antagonist

Akebia joins GSK in US market for oral CKD anaemia drugs

Japan clears first CLDN18.2 drug, Astellas’ Vyloy

MSD leaps on FDA approval of PAH drug sotatercept

At second ask, FDA clears AZ’s Ultomiris for NMOSD

FDA okays Italfarmaco’s non-steroidal DMD therapy Duvyzat

Idorsia first-in-class hypertension drug gets FDA okay

The long-delayed promise of the microbiome, with Sam Possemi...

How to meet your physicians where they are online

regulatory approval

Editor's Picks