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 ...
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 ...
Medscape3 天
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 ...
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 ...
Healio3 天
FDA rejects RP1 for advanced melanoma, says IGNYTE not a ‘well-controlled’ trial
The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license ...
Medscape1 天
FDA Declines to Approve New Melanoma Therapy
In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...
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 ...
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 ...