regulatory approval

News

AZ, Sanofi’s Beyfortus cleared in China for RSV prevention

AstraZeneca and Sanofi’s long-acting antibody Beyfortus has been approved in China for the prevention of respiratory syncytial virus (RSV) infections in newborns and infan

News

FDA approves Ionis, AZ’s Wainua for ATTR polyneuropathy

AstraZeneca and Ionis are planning a US launch next month for Wainua, their treatment for polyneuropathy in life-threatening disease transthyretin-mediated amyloidosis (AT

News

MSD claims 2nd FDA approval for Welireg, in kidney cancer

The FDA has approved MSD’s oral HIF-2 alpha inhibitor Welireg for a second cancer indication, relapsed or refractory advanced renal cell carcinoma (RCC), the most common f

News

Novartis’ Fabhalta is first FDA-cleared oral therapy for PNH

Novartis’ targeted factor B inhibitor iptacopan has become the first oral monotherapy to be approved by the FDA for rare blood disorder paroxysmal nocturnal haemoglobinuri

R&D

How to advance more late-stage neuroscience drugs to regulat...

As a practicing neuropsychiatrist for more than a decade, I witnessed firsthand the profound unmet need in neurological and psychiatric disorders including epilepsy, neurodegenerative disea

News

CSL, Arcturus get first approval for self-assembling RNA jab

Japan’s medicines regulator has approved the first vaccine based on self-assembling RNA, a spin on the mRNA technology used in current shots, which is designed to deliver greater effi

AZ, Sanofi’s Beyfortus cleared in China for RSV prevention

FDA approves Ionis, AZ’s Wainua for ATTR polyneuropathy

MSD claims 2nd FDA approval for Welireg, in kidney cancer

Novartis’ Fabhalta is first FDA-cleared oral therapy for PNH

How to advance more late-stage neuroscience drugs to regulat...

CSL, Arcturus get first approval for self-assembling RNA jab

CDC panel votes to scrap hepatitis B birth dose advice

How to meet your physicians where they are online

regulatory approval

Editor's Picks