News

FDA appoints biotech executive as top drug regulator under RFK Jr.
Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...
FDA staff raises efficacy concerns for Otsuka's PTSD combination treatment
The U.S. Food and Drug Administration's reviewers on Wednesday raised efficacy concerns over the use of Otsuka Pharma's drug ...
Medscape3d
FDA Panel Rejects Brexpiprazole-Sertraline Combo for PTSD
An FDA advisory panel concludes that the efficacy of brexpiprazole, when started concurrently with sertraline, has not been ...
Ophthalmology Times8d
FDA accepts for review Aldeyra Therapeutics’ resubmitted New Drug Application for reproxalap
The FDA accepted Aldeyra's resubmitted NDA for reproxalap after previous rejections due to efficacy concerns, despite no ...
Otsuka’s PTSD therapy draws efficacy concerns at FDA ahead of AdCom meeting
Otsuka Pharma (OTCPK:OTSKY) and H. Lundbeck (OTCPK:HLBBF) draws efficacy concerns for their PTSD therapy from the FDA ahead ...
FDA staff raises efficacy concerns for Otsuka's PTSD combination drug
The U.S. Food and Drug Administration's reviewers have raised efficacy concerns over Otsuka Pharma's combination drug for ...
The Daily Signal1h
EXCLUSIVE: Think Tank Asks FDA for Documents About Abortion Pill
Mike Pence's think tank is asking the Food and Drug Administration to turn over documents related to the dangers of the ...
Applied Clinical Trials Online29m
FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors
Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.
PharmExec1d
FDA Appoints George Tidmarsh as Director of Center for Drug Evaluation and Research
Biotech veteran and Stanford physician-scientist brings 30 years of translational research and regulatory experience to ...
Replimune plunges as FDA rejects its lead drug for skin cancer
Replimune (REPL) stock in focus as the FDA rejects its lead drug RP1 as part of a combination regimen for melanoma, a type of ...
FDA-backed metric used to determine effectiveness of rectal cancer drugs may be unreliable, says new study
A new study by a Tulane University researcher casts doubt on a widely used shortcut in rectal cancer drug trials, raising ...
Psychiatry Advisor4d
FDA Publishes Full Texts of Response Letters to Drug Applications
The US Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted to the agency from ...