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Reporter and editors from the Pink Sheet, Medtech Insight and HBW Insight consider the impact of the layoffs at the FDA on its drug, device and consumer products divisions, as well as the so-far limited public reaction from industry.

Over 140 biopharma leaders share their views on developments to watch for in key therapeutic areas this year. Advances in multiple scientific fields are opening up new avenues for treatment.

The pharmaceutical industry has been quiet on Trump's early federal government overhauls that could harm the drug business, still betting he will help produce better results than Biden.

Nonprofits are finding new ways to address market gaps and develop treatments for rare diseases with little commercial attraction.

For In Vivo's 17th annual Deals of the Year contest, we selected 12 nominees in three categories – Top Alliance, Top Financing and Top M&A. The polls are closed, and it is time to reveal the winners.

With new Phase I/Ib results in kidney cancer, the HIF-2a inhibitor outshines Merck’s Welireg, but longtime Arcus partner Gilead decided not to exercise its option for casdatifan.

Unleashing a trio of major announcements, Formycon has indicated a gloomy outlook for US Stelara biosimilar pricing; revealed plans to pause commercialization of its Sandoz-partnered US Cimerli rival to Lucentis amid discounting from rivals; and set out ambitious plans to win FDA approval for its proposed Keytruda biosimilar without any Phase III data.

Pink Sheet editors and special guest Michael McCaughan of Prevision Policy discuss Robert F. Kennedy Jr.’s first act as HHS Secretary, former FDA Commissioner Scott Gottlieb’s suggestion that industry extend the existing user fee agreement rather than negotiate a new one, and President Trump’s policies impacting FDA advisory committee schedules and staffing.

In the latest episode of the In Vivo podcast, Citeline’s expert panel of reporters and analysts unpack the biggest deals, trends and innovations following the J.P. Morgan Healthcare Conference.

General chapters on pyrogens, histamine and depressor substances – involving tests on rabbits, guinea pigs and cats – are being removed from the Ph. Eur, marking another step in the European Pharmacopoeia Commission’s ongoing efforts to replace, reduce and refine the use of animals for monograph requirements.