Business Wire16h
NDRI CEO Bill Leinweber Appointed to Pennsylvania Organ Donation Advisory Committee
The National Disease Research Interchange (NDRI) is proud to announce that Pennsylvania Governor Josh Shapiro has reappointed ...
JD Supra17h
FDA Advisory Committee outlines informed consent best practices
The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed ...
Hosted on MSN1d
Intercept loses Ocaliva FDA full approval bid in rare liver disease
On the heels of an unfavourable advisory committee (AdCom) meeting ... The drug will continue to be available for patients ...
Lexicon Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Update
Announced Exclusive Licensing Agreement with Viatris for Sotagliflozin in all Markets Outside of the U.S. and EuropeCompleted ZYNQUISTA™ FDA ...
FiercePharma2d
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 Today3d
FDA Rejects Full Approval of Liver Disease Drug
The decision follows a September meeting of the agency's Gastrointestinal Drugs Advisory Committee, which agreed that the ...
BioWorld3d
Icecure wins advisory nod for Prosense system for breast cancer
Early-stage breast cancer patients in the U.S. may soon be able to access another treatment regime based on the result of a Nov. 7 FDA advisory committee for the Prosense cryoablation system by ...
Health on MSN6d
FDA Plans to Ban Ineffective Cold Medicine Ingredient—How It Will Affect You
The FDA has proposed removing phenylephrine, a widely used ingredient to treat nasal congestion, from over-the-counter cold medications.Last year, an FDA advisory committee concluded that the oral ...