FDA

The FDA has approved the IL-23 inhibitor for Crohn's disease to add to its ulcerative colitis approval and put the drug in a position to compete with the likes of AbbVie's Skyrizi and Johnson & Johnson's Stelara.

Supplement and food product firms have until January 2027 and oral drug product firms have until a year later to stop using Red No. 3, FDA decides in approving 2022 petition filed by public health advocacy groups.

Biocon Biologics has announced a change in regulatory status for a manufacturing plant in Malaysia that could pave the way for a pair of long-awaited FDA biosimilar approvals, after similar positive news for an Indian site late last year.

Former FDA commissioners Mark McClellan and Scott Gottlieb, former acting commissioner Janet Woodcock and current commissioner Robert Califf offered advice on successfully implementing reforms and preventing a mass exodus of FDA employees as inklings emerge that the Trump team is already engaged on this front.

Cavazzoni, who led the drugs center four-and-a-half years, decided on her own to retire at this time, sources said. The decision may have been a preemptive move knowing her time as head of CDER would have been limited, or at the very least highly challenging, under the new administration.

ANI Pharmaceuticals will compete with a product bringing in annual sales of more than $150m after launching the first generic with 180-day exclusivity via the FDA’s competitive generic therapy pathway.

Final rule’s requirement that ACNU formulations also remain available as Rx generics could limit revenues for marketers of the nonprescription drugs while approvals of ACNU applications from studies with participants having drugs delivered to their homes may require marketers to limit distribution to direct-to-consumer without clearance for sales in retail stores.

Study completed in 2024 showed consumers using an online application accurately self-selected and safely used an Rx statin drug. An “ACNU” switch NDA would have to first show conventional OTC labeling won’t support proper self-selection and use.

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST.