Tag: accelerated approval

FDA, Regulations

Study points to weaknesses in FDA accelerated approval path

April 9, 2024

Via: Pharmaphorum

That is the conclusion of a study presented at the American Association of Cancer Research (AACR) in San Diego and simultaneously published in the Journal of the American Medical Association (JAMA), looking at 46 cancer drugs given accelerated approvals over […]

FDA, Regulations

Bristol Myers Squibb’s Breyanzi granted FDA accelerated approval for non-Hodgkin lymphomas

March 18, 2024


The regulator’s decision specifically applies to adult patients with relapsed or refractory disease who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor. CLL is one of the […]

FDA, Regulations

FDA sets back Travere’s plans for kidney disease drug approval

May 26, 2021

Via: FierceBiotech

The FDA has crushed Travere Therapeutics’ hopes of seeking accelerated approval in a rare kidney disorder on the strength of existing interim data from a phase 3 clinical trial. Travere said it may have enough data to meet the FDA’s […]

FDA, News, Regulations

FDA commish finding his feet, COVID-19, and chaotic communication hitting speedy approvals

August 26, 2020

Via: FierceBiotech

The FDA’s accelerated approvals program is on shaky ground after a series of surprise rejections, poor communication and COVID-19-focused staff. This is according to analysis by an anonymous FDA consultant out of regulatory firm Prevision Policy, speaking to analysts at […]