News

JD Supra18h
Conditional Approval Proposals for FDA: Current Context and Potential Ramifications
Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...
The FDA’s ‘Bullish Signal’ to Biotech Could Backfire
The notion that we can simultaneously demand expedited approvals while gutting the agency is misguided.
Healio7d
Confirmatory study delay after FDA accelerated approval should be ‘cautionary sign’
Cancer drugs that received accelerated approval from the FDA gained regular approval significantly faster if their ...
STAT5d
U.S. health officials inject new uncertainty into approval process for Covid boosters
Confusion over the Food and Drug Administration’s delay in granting full approval to Novavax’s Covid ... of the company’s submission. In the process, Makary and a spokesman for the ...
Clinical Trials Arena on MSN2d
FDA confirms primary goal for Dimerix’s DMX-200 trial to treat FSGS
The US FDA has confirmed proteinuria as an acceptable primary endpoint in Dimerix ‘s Phase III ACTION3 trial of DMX-200 for ...
Fierce Biotech1d
UPDATE: FDA misses PDUFA date for Stealth’s ultra-rare disease candidate, delaying approval decision—again
An approval decision for Stealth BioTherapeutics’ investigational treatment for an ultra-rare genetic disease has been ...
Renal & Urology News3d
Study Reveals “Substantial Delays” in Withdrawal of Accelerated Approval for Cancer Drugs
There may be “substantial delays” between when a drug is granted accelerated approval for a cancer indication, when negative trial results are released, and when the accelerated approval of the drug ...