Approvals

• Regulatory bodies are increasingly integrating real-world evidence (RWE) into the drug approval process to supplement traditional randomized clinical trials. • This shift utilizes real-world data (RWD) sourced from electronic health records, administrative claims databases, disease registries, and digital health tools. • The adoption of RWE allows for a more comprehensive understanding of patient health and healthcare delivery, potentially accelerating decision-making for pharmaceutical companies.

• The FDA approved Icotyde (icotrokinra), developed by Johnson & Johnson Innovative Medicine, on March 17, 2026. • The drug is an interleukin-23 (IL-23) receptor antagonist specifically indicated for patients with moderate-to-severe plaque psoriasis. • This approval provides a new therapeutic option for managing a chronic inflammatory skin condition by targeting specific immune responses.

Tuesday’s federal budget to include $500m to fund faster approvals for housing, energy and mining projects. Follow today’s news liveGet our breaking news email, free app or daily news podcastGood morning, Krishani Dhanji here with you. Friends, it’s budget week, and it has come very quickly if you ask me!We’re getting a few final announcements from the government before Jim Chalmers hands down his budget tomorrow. That includes some money to speed up environmental approvals to boost productivity (more on that in a moment). Of course, all the big-ticket items – including reforms to capital gains tax, negative gearing and trusts, have already been out for weeks. Continue reading...

Conservationists say move could push species closer to extinction and clearer environmental rules are needed insteadFollow our Australia news live blog for latest updatesGet our breaking news email, free app or daily news podcastConservationists and scientists have warned a mining lobby proposal to use artificial intelligence to speed up national environmental approvals could generate “Robodebt-style” failures, putting threatened species at further risk.The Minerals Council of Australia has asked the government to spend $13m to trial the use of AI to help companies prepare applications and help the federal government make decisions. Continue reading...

• FDA announced on April 1, 2026, that new drug approvals last year reached near-record levels, surpassing five-, ten-, and multi-year averages. • This update highlights continued acceleration in innovative therapies reaching US patients, boosting treatment options for various diseases. • Strong approval momentum underscores FDA's commitment to expediting safe, effective drugs amid public health priorities like cancer and rare diseases.