资讯

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 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 ...
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 Oncology3 天
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 ...
Fierce Pharma8 天
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 ...
Devdiscourse5 天
Health Headlines: FDA Panel Rejects PTSD Drug, Getinge Tops Profits, Bird Flu Hits Spain
The FDA panel voted against Otsuka's PTSD drug combination with Zoloft, questioning its efficacy. Getinge surpassed profit ...
BioSpace8 天
Otsuka, Lundbeck’s PTSD Bid for Rexulti Hits Speedbump as FDA Questions Efficacy
FDA reviewers flag "discordant results" in a briefing document published ahead of Friday's advisory committee meeting for the ...
Psychiatry Advisor4 天
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 ...
Devdiscourse5 天
Health Concerns: PTSD Drug Rejection, Medicare Ratings Dispute, and Bird Flu Outbreak
The FDA panel rejects Otsuka's PTSD drug combination. Humana's lawsuit challenging Medicare rating downgrades is dismissed. Spain reports an avian flu outbreak, causing global supply concerns.
The Munich Eye7 天
Concerns Raised Over FDA-Approved Metric for Rectal Cancer Drug Efficacy
Munich news, health insurance, technology, jobs and other topics for expatriates. The Eye Newspapers covers daily news and offers services for foreigners.
FDA-backed metric used to determine effectiveness of rectal cancer drugs may be unreliable ...
A new study by a Tulane University researcher casts doubt on a widely used shortcut in rectal cancer drug trials, raising ...
来自MSN2月
Could your child's fluoride prescription soon be banned? FDA ... - MSN
The FDA's concern stems from the fact that these products have never received formal approval, raising questions about their safety and efficacy.