Orca Bio’s Orca-T FDA review extended to July 2026

FDA grants priority review to Enhertu for high-risk HER2-positive breast cancer

Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population

Ultragenyx bags FDA priority review for groundbreaking GSDIa gene therapy

If approved, DTX401 would be the first treatment to address the disease at its root cause

FDA accepts Deciphera’s NDA for tirabrutinib in rare aggressive brain lymphoma

The drug targets relapsed or refractory primary central nervous system lymphoma, a rare and aggressive form of non-Hodgkin lymphoma

FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma

Iberdomide has the potential to be the first approved CELMoD agent

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

AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer

The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)

Camurus’ Oclaiz NDA resubmission accepted by FDA

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026

Johnson & Johnson strikes deal With Trump admn to cut drug costs, expand manufacturing

The agreement responds directly to President Trump’s demands that drugmakers cut costs for US patients