The European Medicines Agency said the portal will enable consultations with medical device expert panels that can promote faster access to new technologies.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for an Evrysdi® ...

"The Evrysdi tablet combines established efficacy with convenience, providing an additional flexible option for SMA management." The approval of the Evrysdi tablet was based on the results of a ...

Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and sa ...

Operator Good afternoon, everyone, and welcome to Gilead's fourth quarter and full year 2024 earnings conference call. My ...

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2024.

Gilead Sciences, Inc. GILD reported better-than-expected fourth-quarter results and provided an upbeat guidance for 2025.

Rare diseases have become an attractive target for pharmaceutical companies both on the ASX and internationally.

Despite their market presence, generic veterinary medicine producers face increasing regulatory and financial pressures. While EU regulations have ‘improved harmonisation’ in the sector, they have ...

Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T cells, today announced the ...

(NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for linvoseltamab for the treatment ...