Trump 2.0

Hims & Hers’ Compounded Semaglutide Pill Triggers US FDA Enforcement

The Health and Human Services general counsel referred the online health platform to the Justice Department to investigate potential violations of the Food, Drug and Cosmetic Act after the firm announced it would offer a compounded version of Novo Nordisk’s oral Wegovy.

Pink Sheet Podcast: US FDA Hiring Improves, But Can The Agency Avoid Oversight Erosion?

As the FDA sees another quarter with a net loss of employees in CDER and CBER, Pink Sheet editors discuss the potential impact and where it could manifest.

More America First Fees: US FDA Proposes GDUFA Facility Fee Waiver For Domestic Construction

The FDA wants to waive facility fees for three years if a sponsor breaks ground on a US-based manufacturing plant, but industry is concerned the idea will force other sponsors to subsidize competition.

GDUFA IV: US FDA Seeks To Codify Domestic Manufacturing ANDA Prioritization Pilot

The FDA proposed allowing sponsors that use domestic API suppliers and finished dosage form manufacturing and conduct BE testing in the US to receive a shorter ANDA review.

A Strong Year For US FDA Approvals, But Warning Lights Flashing

The headlines showed a robust tally of new drug approvals from the US FDA in 2025, but cracks are beginning to show that could turn into fissures in the year ahead.

US FDA’s Failure To Implement Key Workforce Reforms Puts Oversight At Risk, GAO Says

Recommendations to mitigate attrition among clinical research and drug manufacturing investigators at the FDA have not been implemented, and a Strategic Workforce Plan aimed at addressing recruiting, retention and training challenges has been shelved, the Government Accountability Office said.

US FDA Review Team Split On Amgen’s Tavneos Years Before Withdrawal Request

The clinical and statistical review teams favored a complete response letter for the vasculitis treatment, while the review division and office directors supported approval.

US FDA’s Failure To Implement Key Workforce Reforms Puts Oversight At Risk, GAO Says

Recommendations to mitigate attrition among clinical research and drug manufacturing investigators at the FDA have not been implemented, and a Strategic Workforce Plan aimed at addressing recruiting, retention and training challenges has been shelved, the Government Accountability Office said.

US FDA’s Drugs, Biologics Centers See Increased Hiring, But Not Enough To Overcome Departures

CDER and CBER added more people in the first quarter of FY 2026 than the previous two quarters combined, but departures still outnumbered the additions.

PBM Reform Bill Passes US Congress, But More Changes Likely Not Imminent

The US Labor Department also added a proposed rule requiring PBMs to disclose additional compensation information to certain employer-plan sponsors.

US FDA’s Failure To Implement Key Workforce Reforms Puts Oversight At Risk, GAO Says

Recommendations to mitigate attrition among clinical research and drug manufacturing investigators at the FDA have not been implemented, and a Strategic Workforce Plan aimed at addressing recruiting, retention and training challenges has been shelved, the Government Accountability Office said.

More America First Fees: US FDA Proposes GDUFA Facility Fee Waiver For Domestic Construction

The FDA wants to waive facility fees for three years if a sponsor breaks ground on a US-based manufacturing plant, but industry is concerned the idea will force other sponsors to subsidize competition.