Asia-Pacific Pharma Intelligence Center

PMDA launched a new 'Overview of Orphan Drug Designation' website on May 22, 2026, centralizing information for sponsors.

The Therapeutic Goods Administration (TGA) is the Australian Government's regulatory authority for therapeutic goods, including medicines, medical devices, and biologicals .

The FDA delivered a busy run of decisions in oncology, biosimilars, and consumer drug safety on May 18, 2026, as reported by The Pharma Letter, while the EMA continued its monthly approval cycle after an active CHMP meeting in late April.

A nationwide cohort study published in Hypertension Research assessed the effects of hypertension burden and blood pressure control on dementia across different age subgroups .

Hengrui Pharma and Kailera Therapeutics presented Phase 2 data for oral ribupatide (HRS9531) at the American Diabetes Association 86th Scientific Sessions (ADA 2026).

Rezpegaldesleukin (REZPEG, or NKTR-358) is a first-in-class regulatory T cell stimulator being developed by Nektar Therapeutics.

Durable survival benefit confirmed: The HERIZON-GEA-01 trial demonstrated durable progression-free and overall survival, establishing a competitive efficacy signal in gastroesophageal adenocarcinoma (GEA), an indication with high unmet need and limited late-stage treatment advances.

The global injectable drug delivery market is expected to reach US$1182.2 billion by 2033 , up from US$655.1 billion in 2026 , according to Persistence Market Research. Source: PR Newswire UK

Kissei Pharmaceutical confirmed 20 deaths in Japan linked to Tavneos (avacopan), with liver dysfunction identified as the primary cause of fatalities, prompting the company to ask doctors to halt new prescriptions.