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 ...
FDA delays approval decision for Bayer menopause therapy
The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...
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 ...
Targeted Oncology3d
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 ...
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 ...
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 ...
The Daily Signal11h
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 ...
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 ...
Fierce Pharma8d
FDA advisors spurn GSK's Blenrep comeback dreams on safety, trial concerns
On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...
US FDA advisers vote 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 ...
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 ...
The American Journal of Managed Care3d
FDA Issues CRL for Vusolimogene Oderparepvec in Advanced Melanoma
The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.