News

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 ...
Targeted Oncology1d
FDA Issues CRL for RP1 in Advanced Melanoma
Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete ...
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 ...
Applied Clinical Trials Online1d
FDA Issues Complete Response Letter to Replimune for RP1 Combination Therapy in Advanced Melanoma
The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (CT03767348) trial in advanced melanoma was not ...
US FDA advisers recommend against Otsuka's PTSD combination treatment
The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...
Medscape1d
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 ...
PharmExec3h
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 ...
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 ...
FDA to review prescription fluoride supplements for kids at risk for tooth decay
The Trump administration is inching closer to banning fluoride tablets and drops often prescribed to kids who don’t have ...
Fierce Pharma3h
FDA delays Blenrep decision, putting GSK's multiple myeloma comeback dreams on ice
Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...
Psychiatry Advisor2d
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 ...