Centivax launches first human trial of universal flu vaccine

FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue

The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”

Precision BioSciences cleared by FDA to launch groundbreaking Duchenne gene editing trial

PBGENE-DMD is designed to permanently correct mutations in the dystrophin gene between exons 45 and 55, the “hot-spot” region affecting roughly 60% of DMD patients

Merck’s KEYTRUDA bags FDA nod for platinum-resistant ovarian cancer

KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to its components

Veradermics completes enrollment in both Phase 3 male hair loss trials

The milestone means more than 1,000 men are now enrolled across both Phase 3 programs

Roche BTK drug emerges as potential breakthrough in primary progressive MS

Aicuris’ Pritelivir delivers Phase 3 win in hard-to-treat herpes patients

The PRIOH-1 study met its primary endpoint, delivering statistically significant and clinically meaningful improvements in lesion healing

Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke

These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke

Zydus receives USFDA ODD for Desidustat for the treatment of sickle cell disease

This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease

Pfizer’s HYMPAVZI bags FDA priority review, targeting younger & hard-to-treat hemophilia patients

HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors