United States
The online health platform relented after the Health and Human Services general counsel referred the company to the Justice Department to investigate potential violations of the Food, Drug and Cosmetic Act.
Richard Pazdur plans to remain involved in drug development after leaving the FDA.
Obesity will continue dominating the cadiovascular, renal and metabolic field in 2026, but the US FDA's Commissioner's National Priority Voucher program could disrupt the user fee calendar throughout the vast sector.
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.
The sales opportunity in Medicare Part D and Medicaid arrives as Lilly and Novo Nordisk face a new competitive threat from compounded semaglutide for obesity.
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.
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.
The agreement covers the gamut of often criticized PBM tactics and includes commitments to pass price concessions to consumers.
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.
The UK-US trade deal offers the “the most encouraging signs the industry has seen for many years,” but UK companies had little influence over it and details are still scarce, according to one industry expert.
Amgen's refusal to voluntarily withdraw the rare disease treatment could force the FDA to employ its formal process to remove it from the market.
The US Labor Department also added a proposed rule requiring PBMs to disclose additional compensation information to certain employer-plan sponsors.
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.
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.
New terms of reference for the Advisory Committee on Immunization Practices’ overhauled work groups on influenza, HPV and RSV reflect some members' broader concerns about the potential long-term adverse effects of vaccination.
Two flu vaccine labels already include febrile seizure in the clinical trial and postmarketing experience sections of the label, but the FDA wants all of them to add a warning of the adverse event.
The FDA does not like the idea, in part because estimating annual revenue likely would be tougher.
The unusual revision of Corcept’s complete response letter suggests the FDA may be writing for a different audience now that unapproved product CRLs are being made public.
Accelerated approvals of novel products rebounded in 2025 as drug development adapted to major pathway changes enacted in the FDA Omnibus Reform Act, but pending applications suggest a potentially bigger impact outside oncology in 2026.
Pink Sheet editors discuss new information on the Commissioner’s National Priority Voucher Program, including the role of the center directors and the Commissioner’s National Priority Voucher Review Council in application reviews.