Pink Sheet
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.
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.
Improving patient recruitment speed will determine the future of the UK’s clinical trials landscape, experts argued at a webinar on the next steps for clinical research in the country.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The Trump administration has launched TrumpRx, a website the White House says could help save Americans billions in pharmaceutical spending, although it does not itself sell or dispense drugs.
A new report identifies opportunities to implement the 3Rs principle in India, calling for a waiver of redundant animal testing for generics and NCEs/NBEs and alignment with global regulatory frameworks. Will India shift gears to adopt harmonized NAM-first policies?
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 trade association Medicines Australia has set out key priorities for the government’s upcoming budget announcement in light of worsening access to innovative medicines for Australian patients.
External reference pricing is one of several drug pricing control measures used by a number of countries to contain drugs prices.
At a recent discussion in South Korea, CEPI and other participants explored ways to discover new health cooperation models that go beyond traditional aid approaches and to strengthen Korea’s role.
The agreement covers the gamut of often criticized PBM tactics and includes commitments to pass price concessions to consumers.
The clinical and statistical review teams favored a complete response letter for the vasculitis treatment, while the review division and office directors supported approval.
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.
Sponsors are increasingly using Bayesian methods in clinical trials, prompting the European Medicines Agency to evaluate how it can address a lack of “clarity” around when this is acceptable.
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.