Roche (RHHBY) announced that the Food and Drug Administration has approved a New Drug Application for an Evrysdi tablet for people living with ...

SpringWorks Therapeutics (SWTX) announced that the U.S. FDA has approved Gomekli, SpringWorks’ MEK inhibitor, for the treatment of adult and ...

The U.S. Food and Drug Administration (FDA) has approved monthly maintenance dosing for Leqembi (lecanemab), a treatment for early Alzheimer’s disease. “The approval of once every four-week ...

BMS’ cancer combo is up for a similar approval in the U.S., with the FDA scheduled to make its decision on a potential first-line unresectable HCC nod by April 21. The drugmaker also won a CHMP ...

The FDA is reviewing the application for bentracimab for use as a ticagrelor reversal agent in patients with uncontrolled bleeding or in those who require urgent surgery or invasive procedure.

Providers are sympathetic to Medicare enrollees’ concerns but don’t agree on their role in helping patients find less costly ...

Amicus Therapeutics’ first oral drug for the rare condition Fabry disease has been approved by the FDA, giving patients an alternative to conventional injected enzyme replacement therapy.

New Delhi, Feb 10 (PTI) Sanofi Healthcare India on Monday said it has received marketing authorisation for a drug used for the treatment of Chronic graft versus host disease (cGVHD). The company has ...

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed. Recent ...