But now the FDA has rubber-stamped the approval of Luxturna, the first ever gene therapy it has backed, all the attention is now on Spark, and what price it plans to charge for the therapy.

"The FDA anticipates that there will be an adequate and diverse supply of approved trivalent seasonal ... saying he believed VRBPAC was merely 'rubber stamping' the decisions made by the WHO's ...

The so-called "mainstream" media — a festering menagerie of corporate whores, ideological janissaries, and risk-averse ...

Medtronic has secured a green light from the FDA to connect its latest automated insulin pump with its newest continuous ...

The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) to treat adults and ...

The FDA approved dupilumab (Dupixent) for chronic spontaneous urticaria (CSU) in patients 12 years and older, the first new ...

The FDA has approved a prefilled syringe formulation of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) that allows patients to self-inject the medication.

"Today's FDA approval provides a new self-injection option across both approved indications in the U.S. that is designed for patients who seek more independence with their treatment," said Luc ...

The FDA announced it will be reducing, refining and potentially replacing the animal testing requirement for the approval of ...

Sanofi and Regeneron's fully human monoclonal antibody Dupixent (dupilumab) has gained approval from the US Food and Drug ...

Several studies reported reduced itch severity and urticaria activity with dupilumab. The FDA approved dupilumab for the treatment of patients 12 years and older with chronic spontaneous urticaria ...

The U.S. Food and Drug Administration has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for adults with unresectable or metastatic hepatocellular carcinoma (HCC).