The U.S. Food and Drug Administration (FDA) has granted full approval of Laverdia, a drug to treat dogs with lymphoma, a type ...

This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...

The US FDA approved 46 new drugs in 2025, despite a tumultuous year at the regulatory agency.

The Trump administration faces scrutiny from some pro-lifers over the Food and Drug Administration's recent approval of a new ...

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency ...

The US saw several new and expanded FDA indications this year. The top 5 most-read FDA approvals on AJMC.com included 4 novel therapies and 1 expanded indication, reflecting the growing number of ...

The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing ...

On August 8, 2025, the FDA granted accelerated approval to zongertinib for adult patients with unresectable or metastatic nonsquamous NSCLC harboring HER2 (ERBB2) tyrosine kinase domain (TKD) ...

The FDA has approved Zycubo (copper histidinate) injection as the first and only treatment of Menkes disease in pediatric ...

46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...

The FDA has granted full approval to verdinexor tablets (Laverdia; Anivive Lifesciences) for the treatment of dogs with lymphoma. The approval gives veterinarians a promising new oral avenue for ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...