U.S. Food and Drug Administration states that data from the ongoing OnPrime/GOG-3076 Phase 3 registrational trial could potentially support ...

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

Milestone Pharmaceuticals faces a pivotal FDA PDUFA decision for etripamil in PSVT. Read here for a detailed investment ...

In the lower dose group, 19.1% of patients achieved this endpoint, a 10.3% difference vs ... and its safety and efficacy have not been evaluated by the US FDA or any other regulatory authority. Amgen ...

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 ...

Revuforj (revumenib) is an oral, first-in-class menin inhibitor that is FDA approved for the treatment ... treatment of R/R acute myeloid leukemia (AML) with a nucleophosmin 1 mutation (mNPM1).

AstraZeneca is preparing to talk to the FDA about a potential new use of its ... Event-free survival is the primary endpoint of Matterhorn, while pCR is a secondary endpoint.

The FDA is expected to decide on treatments for ... The Company is seeking approval for acute treatment of migraine with or without aura.

The US Food and Drug Administration (FDA) has approved Stoboclo (denosumab-bmwo ... which continued through week 78. The primary endpoint was the percent change from baseline in lumbar spine ...

and it is now setting up a submission for approval to the US Food and Drug Administration (FDA). The US-based biopharma said that the Phase III ALLEVIATE-2 trial (NCT06423703) of its therapy, ...