Regulatory and Standard Setting Organizations

Antisense oligonucleotides are reshaping drug design, from RNase H gapmers to inhaled delivery; this FAQ explains how they work and why trials still fail.

Manufacturing remediation, not efficacy or safety data, is delaying US approval of Novo's h+emophilia A therapy denecimig.

Doubled drug substance capacity at Alvotech's Reykjavik, Iceland, site aims to secure steady US supply of the Humira biosimilar Simlandi.

LumaLex Law's Dustin Robinson explains why retatrutide compounding remains illegal regardless of the Seventh Circuit's pending classification ruling.

FDA has accepted for review the biologics license application for FYB206, a proposed pembrolizumab biosimilar developed without a comparative phase 3 efficacy trial. A decision could come in the third quarter of 2027.

MT027, T-MAXIMUM's B7-H3 CAR-T therapy, earns a second FDA-cleared phase 2 trial, now testing lung and breast cancer brain metastases.

Genglycos, the gene therapy that earned the voucher, will fund new Ultragenyx therapies for other rare and ultra-rare diseases.

AbbVie's c-Met ADC Temab-A showed a 15.6% response rate in late-line colorectal cancer ahead of its 2 new FDA breakthrough designations.