On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...

On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...

The approval adds a new indication for GLP-1 drugs and gives Novo an advantage over Lilly’s rival diabetes drug Mounjaro, ...

The approval of Axsome Therapeutics’ Symbravo for migraine with or without aura came alongside the greenlight for Vertex's ...

FDA clears United Therapeutics for human trials of pig-to-human kidney transplants. Trial involves gene-edited pig kidneys ...

Just days after the FDA approved AstraZeneca and Daiichi Sankyo's Enhertu for a potentially lucrative new use, the regulatory has now cleared a diagnostic test that could help unlock the drug's ...

In a significant development for organ transplantation, two U.S. biotechnology companies, United Therapeutics and ...

NeurAxis offers FDA-cleared IB-Stim device for pediatric IBS pain. Despite positive advancements, market recognition lags.

The US Food and Drug Administration (FDA) has approved a novel formulation combining rizatriptan and the nonsteroidal anti-inflammatory drug meloxicam (Symbravo, Axome Therapeutics) for the acute ...

It’s not cleared for chronic pain. “Today’s approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, MD, acting director of the FDA’s ...

EssilorLuxottica has received approval in the US and EU to market its Nuance audio glasses, a device that combines hearing ...

Vertex has attracted interest from Wall Street for its ambitious drug pipeline that involves winning FDA approval for multiple ... certain semiautomatic rifles clears Senate committee in first ...