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 ...

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...

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

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

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

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

On January 3, 2025, outgoing US Surgeon General Dr. Vivek Murthy released a new advisory outlining the alleged causal link between alcohol ...

Received overwhelming shareholder support in favour of take-private transaction with AditxtAdvanced key pipeline programs, engaged regulatory ...

Reports fourth quarter revenues of $1.0 billion, GAAP net loss of $(1.1) billion and GAAP EPS of $(2.91); loss includes approximately $0.2 billion of non-cash charges related to manufacturing resizing ...