Technologies announces its role in supporting Autolus Therapeutics’ FDA approval for AUCATZYL, a recently approved CAR T therapy.

conducted a review of the Food and Drug Administration (FDA) accelerated approval pathway for prescription drugs, to better understand the extent to which the FDA’s review varied throughout the ...

Upcoming market catalysts for the second quarter of 2025 include the US approval decisions for clesrovimab (MK-1654) for respiratory syncytial virus (RSV) prophylaxis, sebetralstat for hereditary ...

“Making these chemicals immediately illegal until obtaining FDA approval may cause disruptions in the food supply. Ensuring that existing GRAS chemicals are safe to remain in our foods should be ...

The FDA is reviewing the supplemental NDA for cabozantinib in ... absorption and robust efficacy compared with existing DHE products. The Company is seeking approval for acute treatment of migraine ...

In two randomised phase 3 studies involving 480 participants aged 12 years and over, ivacaftor/tezacaftor/vanzacaftor was found to be as effective at improving lung ...

including telehealth and drug companies that sell compounded versions of FDA-approved drugs. The Associated Press Health and Science Department receives support from the Howard Hughes Medical ...

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.

Google wasn't allowed to unlock that feature in the US until it got regulatory approval, but the Food and Drug Administration has finally given Google the go-ahead to activate Loss of Pulse Detection.

A developmental drug that aims to extend the healthy lifespan of senior dogs has received acceptance by the FDA’s Center for Veterinary Medicine for the Reasonable Expectation of Effectiveness (RXE) ...