In 1992, the Food and Drug Administration (FDA) initiated the Accelerated Approval Program to “allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need” based ...

The Food and Drug Administration’s (FDA’s) looming decision over whether to pull the preterm birth drug Makena (hydroxyprogesterone caproate) has reignited debate over their accelerated approval ...

The FDA’s oncology department, under the leadership of Richard Pazdur, M.D., is getting tougher on accelerated approvals for cancer drugs. When considering accelerated approvals for oncology therapies ...

In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory trials at least be underway at the time of these conditional nods. But, after ...

Please provide your email address to receive an email when new articles are posted on . A seated saline suppression test had a high false-negative rate for predicting response to primary aldosteronism ...

Please provide your email address to receive an email when new articles are posted on . SANTA BARBARA, Calif. — A photodynamic therapy agent for the treatment of age-related macular degeneration will ...

The planned confirmatory Phase 3 trial, TELLOMAK 3, aims to demonstrate efficacy of lacutamab in patients with Sézary syndrome (SS) and Mycosis fungoides (MF), who failed at least one prior line of ...

Travere Therapeutics stock tanked yesterday as the company reported its kidney disease drug FILSPARI had failed to meet its key endpoint in a confirmatory study. TVTX shares fell to ~$8 - down 40% for ...

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today reported positive results from a bias analysis conducted for its concluded Phase 3 study of Multikine (Leukocyte ...

New findings challenge recommendations from the European Association of Urology. New findings challenge European Association of Urology (EAU) guidelines that recommend refraining from confirmatory ...