Stereotaxis' holistic ecosystem approach aims to solve long-standing issues with robotic adoption in EP. See why STXS stock ...

Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track ...

J&J is seeking approval of TREMFYA for paediatric conditions with the submission of two sBLA to the US Food and Drug Administration.

The FDA also used accelerated approval for the initial clearance of asciminib in 2021 for use in CML previously treated with ...

The End-of-Phase 2 meeting resulted in alignment with the FDA on the proposed Phase 3 study design, including the inclusion/exclusion criteria, primary and secondary efficacy objectives, definition of ...

IMKELDI is the first oral liquid form of imatinib for specific leukaemia cancer forms. Credit: Jo Panuwat D/Shutterstock. The US Food and Drug Administration (FDA) has approved Shorla Oncology‘s ...

Nearly a year after receiving federal approval to import lower-cost prescription drugs from Canada, Florida's ambitious ...

Acoramidis is the first FDA-approved treatment for ATTR-CM with near-complete TTR stabilization, reducing cardiovascular death and hospitalization. The phase 3 ATTRibute-CM trial showed acoramidis ...

Pharmaceutical consultants accelerate the drug development process by applying deep expertise in therapeutic areas.

The FDA's Orphan Drug Designation is intended to encourage the development of treatments for rare diseases. Orphan Drug Designation offers benefits including seven years of market exclusivity ...

The pilot by the FDA’s CDRH will improve communications about corrective actions being taken over certain medical device ...