Vimseltinib is now an FDA-approved treatment for patients with tenosynovial giant cell tumor, based on findings from the ...

Alnylam awaits FDA decisions on Amvuttra & Fitusiran next month, poised to boost revenue, profitability, and share growth.

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...

Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable ...

GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...

The Ghana Food and Drugs Authority (FDA) has spearheaded a joint initiative with National Regulatory Authorities (NRAs) in ...

Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, today ...

The intravenous antibiotic Emblaveo, a combination of aztreonam and avibactam approved in Europe last year, was developed in ...

Dr. Tycel Phillips discusses the implications of the FDA approval of Calquence plus bendamustine and Rituxan in previously untreated mantle cell lymphoma.

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

Stereotaxis gains CE Mark for MAGiC catheter, boosting revenue with high margins. FDA approval expected soon. Click here to ...