To date, Leqembi has been approved in the US, Japan, China, South Korea, Hong Kong, Israel, UAE, GB, Mexico, and Macau, and ...

The FDA wrapped up 2024 with 50 new drug approvals, clearing a wave of long-awaited treatments. Meanwhile, Transcarent will ...

Recent studies implicate the immune system and a herpes virus as potential contributors to development of disease ...

Stay updated on the latest potential FDA drug approvals in 2025, including an expanded label for Ozempic and new, nonopioid painkillers.

The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new small molecules, biologics and oligonucleotide therapeutics last year. The class of 2024 was a little smaller than that ...

Independence Blue Cross has instituted an 18-month benefit exclusion on certain drugs that receive accelerated approval from ...

The FDA approved a wide range of therapies in 2024, including many new molecular entities and biological products.

Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy ...

Thousands of Americans are diagnosed every year with Parkinson’s Disease. It’s a movement disorder that affects the central ...

Patrizia Cavazzoni, leader of the FDA's Center for Drug Evaluation and Research, is leaving the agency on Jan. 18.

As the second oral therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer’s disease during the past decade, ZUNVEYL demonstrates a potentially better safety ...