PharmaTher Secures FDA Meeting for Ketamine Drug
PharmaTher Holdings Ltd (TSE:PHRM) has released an update. PharmaTher Holdings Ltd. has secured a meeting with the FDA to address a complete ...
FiercePharma1d
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
MedPage Today2d
FDA Rejects Full Approval of Liver Disease Drug
Opens in a new tab or window The FDA declined to grant full approval to obeticholic acid (Ocaliva) for treating primary ...
JD Supra21h
Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and ...
manilatimes1d
PharmaTher Announces Post Complete Response Letter Clarification Meeting Request Granted from the FDA for Ketamine Abbreviated New Drug Application
PharmaTher Holdings Ltd. (the "Company” or "PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the Company requested a post-complete letter clarification ...
FiercePharma1d
After election, FDA's Califf lays out hopes for his Trump-appointed successor
“I think ability to function as an executive is going to be a very important one,” Califf said Tuesday at the Friends of ...
FDA proposes ending use of decongestant found in many cold, allergy medicines
An extensive review determined that the ingredient, oral phenylephrine, doesn’t actually relieve nasal congestion.
Hosted on MSN3d
IMNN: Meeting with FDA in Preparation for Phase 3 Ovarian Cancer Trial
As part of the process, the company will be conducting an ‘End-of-Phase 2’ meeting with the FDA later this month to get input from the agency on their proposed trial design. The study is likely to ...
MM&M1d
FDA rule on TV drug ads: compliance boon or comprehension bust?
Set to become compulsory Nov. 20, the regulation isn't likely to make pharma ads easier for consumers to comprehend, but ...
Altimmune Announces Successful Completion of End-of-Phase 2 Meeting with FDA for Pemvidutide in the Treatment of Obesity
Company and Agency aligned on key efficacy and safety measures to be studied in Phase 3 programPivotal Phase 3 trials designed to leverage the ...
Investing10d
Kazia sets FDA meeting for glioblastoma drug pathway
SYDNEY - Kazia Therapeutics Limited (NASDAQ: KZIA), an Australian biotechnology firm, has secured a Type C meeting with the U.S. Food and Drug Administration (FDA) set for December 2024 to discuss ...
Targeted Oncology7d
FDA Clears Phase 2 Trial of Leronlimab for Microsatellite-Stable CRC
The FDA recently approved a phase 2 clinical trial to investigate the efficacy of leronlimab in patients with relapsed or ...