CorTec said it received a second breakthrough device designation for its investigational Brain Interchange device for use to ...

The Rare Disease Endpoint Advancement and Model-Informed Drug Development programs eventually will drop participation limits ...

A Delaware federal court has entered a $245.2m judgment in favor of TwinStrand Biosciences in a patent infringement case ...

The firm has revealed the extent of the win seen in the ACACIA-HCM study in patients with symptomatic non-obstructive ...

The decision comes as FDA employees face an already strained compensation environment and President Trump this week ...

A survey of 194 life sciences and medtech professionals showed that 63% expect AI investments to rise in 2027 with the ...

The FDA has selected Epitel's wearable EEG system and Prapela's infant cardiac device as the first participants in its ...

Roivant’s Priovant subsidiary gained US approval of brepocitinib in dermatomyositis. Priovant is pursuing additional ...

Adapting to the challenges of Most Favored Nation pricing is a top priority in biopharma boardrooms, though the pricing gulf ...

Japan's latest batch of approval recommendations include global-first nods for anselamimab for kappa light chain amyloidosis ...

Combining long reads with AI, pangenome references and diploid assembly could dramatically improve genetic disease diagnosis, ...

Indian firms lead Paragraph IV filings in the US as a wave of blockbuster drugs lose exclusivity between 2026-2028, but the ...