United States

In a somewhat surprising move, president Donald Trump’s Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon told Generics Bulletin what it means for the generic drug industry.

After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Zydus Lifesciences said it would be able to leverage supply chain dynamics and a “favorable geopolitical environment” to expand its reach in the US and globally as it penned a trio of agreements to plant its flag in the global CDMO space.

Winterman moves from AstraZeneca to lead Perrigo supply operations; SunsolveMD fashions a brand ambassador in Elsa Hosk; Former P&G marketing exec Davis-Artis joins Godrej; and Epidiolex developer Wright advises BRC Th

A weak second half in Glenmark’s India business during the firm’s 2025 financial year took the gloss off its earnings somewhat for the year. However, Glenmark is plotting several avenues to return to growth, in both of its core business regions: India and the US.

Marking most strident use of authorities it received in 2020 as part of an overhaul of monograph system, FDA publishes proposal to shift orally disintegrating formats to individual-dose packaging and a related proposal to minimize firms’ regulatory burden for making delivery format changes potential

HELP members state frustration with layoffs at FDA and pose questions about topics from generic drug approvals to OTC switches, and from manufacturing location labeling to whether the federal agencies intrude on US consumers. Still, acting CDER director Jacqueline Corrigan-Curay makes clear the resu

Generic competition to Eisai’s oral-dose blockbuster cancer therapy Lenvima is set to materialize in the US in 2030 – however, for now, that won’t be from ANDA filer Shilpa Medicare.

Results of survey found a majority of representative sample of US voters nationwide agree “current regulations should be updated and strengthened to protect consumers,” CHPA says.

CRN Foundation selects National Association of Free and Charitable Clinics for Access Initiative support for increasing access to high-quality dietary supplements and essential nutrition for underserved populations.

The US MFN executive order is the latest in a series of concerning US developments that are contributing to uncertainty for the European pharmaceutical industry, according to France Biotech’s vice president, Alexandre Regniault.

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now