Opthea Announces Completion of Drug Substance PPQ Campaign Validating Manufacturing Process of Sozinibercept
Three consecutive commercial-scale batches successfully producedMajor milestone for potential BLA filing of sozinibercept in wet AMDProgress ...
US FDA staff questions confirmatory trial data for Intercept's liver disease drug
Staff reviewers at the U.S. Food and Drug Administration said on Wednesday a confirmatory trial did not show the ...
In the U.S., opioid-maker Purdue is bankrupt. Its global counterparts make millions.
Tactics used to persuade U.S. doctors that potent painkillers could be safely prescribed have been used abroad, an ...
GLP-1 drugs could help prevent 34,000 heart attacks and strokes in the US each year, research suggests
Certain blockbuster weight-loss drugs have been found to protect the heart in significant ways, and new research suggests ...
FDA advisers unconvinced by Intercept's liver disease drug benefits, safety
Independent advisers to the U.S. Food and Drug Administration voted on Friday against confirmatory trial data for Intercept Pharmaceuticals' liver disease drug, putting into question the treatment's ...
US FDA approves Eli Lilly's drug for eczema
Eli Lilly said on Friday the U.S. Food and Drug Administration approved its eczema drug for use in adults and children above ...
infectiousdiseaseadvisor.com10d
FDA Drug Approval Decisions Expected in October 2024
The PDUFA date refers to the deadline set by the US Food and Drug Administration for reviewing drug applications.
1 in 4 adults would consider using weight loss drugs without prescription: Study
Around 25 percent of U.S. adults said they would consider using prescription weight loss medications, like Ozempic or Wegovy, ...
News Nation on MSN6d
Why Haitian immigrants are moving to Springfield, Ohio
Haitian immigrants have moved to Springfield, Ohio, in recent years seeing in the area an opportunity to rebuild.
FiercePharma3d
Intercept's liver med Ocaliva takes heat at FDA expert meeting, as hopes for full approval dim
Following a meeting with the FDA’s Gastrointestinal Drug Advisory Committee Friday, the future of Intercept’s rare liver ...
PBS10d
Ohio city with Haitian migrant influx thrust into political spotlight
Springfield, Ohio, is at the center of one of the most fraught issues in this election. GOP vice presidential candidate JD ...
Medpage Today on MSN6d
Approved Liver Disease Drug Has No Clinical Benefit, FDA Panel Says
Obeticholic acid had been awarded accelerated approval by the FDA in May 2016 as a second-line treatment for PBC patients not ...