Tag: Drug approval process
Reforming FDA Advisory Committee Policy for Conflict of Interest-Free Decisions
Peter J. Pitts, a distinguished figure in the realm of healthcare regulation, recently shared his insights on the critical issue of FDA Advisory Committee policy. Pitts, who served as the senior official in charge...
FDA Considers PDUFA Changes and Compounded Weight Loss Drugs
It's a beautiful morning at the Pharmalot campus, where the sun is shining, and a gentle breeze is blowing. The short person is still catching some Z's, and the official mascots are on guard...
Reforming FDA to Help Rare Disease Patients
President Donald Trump has the potential to revolutionize the landscape of rare disease treatments and save countless American lives through strategic policy changes, innovative science, and strong leadership within government agencies. This ambitious claim...
Challenges at FDA & bluebird Bio Sale: What You Need to Know
This morning, Praxis Precision Medicine announced that an independent data monitoring committee recommended discontinuing a Phase 3 study involving its experimental treatment for essential tremors. The analysis indicated that the drug was unlikely to...
Apellis Triumphs while Astellas Faces Defeat
Good morning! Today, there is a lot of news from the American Heart Association's annual meeting, and former National Cancer Institute chief Ned Sharpless has launched a new biotech company called Jupiter.
Here's what you...
New Title: Soft-Tissue Cancer Drug Approval and Zepbound Shortage Update: Pharmalittle News
Good morning, this is Jonathan Wosen, reporting on the latest news in the biotech and life sciences world. The FDA has recently approved a new treatment for a rare soft tissue cancer. This cutting-edge...
