The FDA's nod to IONS' Tryngolza makes it the first approved treatment for FCS. It is also the company's first wholly-owned drug to receive marketing...

Microbot Medical announces the submission of its LIBERTY System for FDA marketing clearance.

AngioDynamics' latest regulatory approval is likely to pave the way for an alternative to conventional radical surgery and improve patient outcomes.

An Australian company has been given first-of-its-kind approval to launch a rocket out of a small Queensland town.

An Australian company has been given first-of-its-kind approval to launch a rocket out of a small Queensland town.

The US FDA has scheduled a pre-approval inspection of EBR System’s WiSE CRT System for the week of January 6, ...

uniQure stock rallies 110% on reaching alignment with the FDA on key elements of an accelerated approval pathway for AMT-130 to treat Huntington's...

The CHMP recommends marketing approval to GSK's Vocabria plus JNJ's Rekambys for treating HIV-1 infection in adolescents aged 12 years and older.

The FDA approves Mesoblast's Ryoncil (remestemcel-L) for treating pediatric patients with steroid-refractory acute graft versus host disease. Shares...

The FDA approves Mesoblast's Ryoncil (remestemcel-L) for treating pediatric patients with steroid-refractory acute graft versus host disease. Shares...