The Pink Sheet

Health and Human Services Secretary Robert F. Kennedy Jr. said criticism of FDA Commissioner Martin Makary stems from industry anger over tougher evidentiary standards. RFK Jr. defended FDA Commissioner Martin Makary's record during a House Ways and Means Committee hearing. (Screenshot of Committee Broadcast) Key Takeaways Rep. Darin LaHood, R-IL, warned that inconsistent FDA review decisions risk driving biopharma investment overseas, particularly to China.

The FDA’s Pharmacy Compounding Advisory Committee review of peptides is an early policy step, but rulemaking and manufacturing constraints may delay its impact. An FDA advisory committee will consider lifting restrictions on some peptides after the agency restricted them in 2023.

The vetting of ophthalmologist and cable news pundit Houman David Hemmati, who is a biotech company founder with big pharma industry experience, to head CBER could signal a shift in FDA thinking about the center director credentials. Houman David Hemmati, right, is reportedly a candidate for CBER Director. He has made several appearances on Fox News.

The agency's drugs and biologics centers added many new faces in the FY 2026 second quarter, but departures still outnumbered new hires, causing overall counts to drop again. CDER hired more people in the FY 2026 second quarter, but could not outpace departures. (Shutterstock) Hiring at the US Food and Drug Administration’s Center for Drug Evaluation and Research reached another post-RIF peak in the fiscal year 2026 second quarter, but the net effect once again was a loss of staff.

By leveraging existing safety data from related compounds, Cereno is charting a faster, more cost efficient path for CS014 – a regulatory strategy that could reshape timelines, reduce risk, and offers a blueprint for cash strapped biotechs.

Key Lever For Regulatory Reforms China’s national regulator launches plan for use of AI, outlining computing infrastructure and use of open data, and stressing the need for clear boundaries. China’s top drug regulator rolls out more comprehensive plans on implementing AI in drug regulation after a few years of exploration.

Concerns Over API, Drug Supplies South Korea's government and pharma industry are taking coordinated emergency steps to monitor and prevent possible shortages in drug and medical supplies which could arise from naphtha supply disruptions.

The FY 2027 budget request includes additional funding to support opening offices in Tokyo and Hanoi to support foreign inspection work. New FDA foreign offices are planned for Tokyo and Hanoi. (Shutterstock) Key Takeaways The FDA’s FY 2027 budget request includes additional funding to help establish new foreign offices in Hanoi, Vietnam and Tokyo. The US Food and Drug Administration is planning to expand its footprint in Asia, although the location of the new... Trump 2.0

Steve Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, a powerful industry trade association, will step down at the end of 2026. Ubl has been head of PhRMA since 2015, the longest tenure of any CEO of the...

The US FDA and industry agreed that in PDUFA VIII sponsors would pay a reduced application fee if their Phase I clinical trials were anchored in the US, but eligibility requirements are unclear. Phase I clinical trials anchored in the US could receive a 50% application fee discount in PDUFA VIII. (Shutterstock) Key Takeaways Sponsors conducting Phase I clinical trials “anchored” in the US would pay half the application fee in PDUFA VIII.