FDA vaccines chief hopes for common ground with RFK Jr.
The FDA's Dr. Peter Marks says he hopes to keep his job under a second Trump term, and urges Robert F. Kennedy Jr. to "keep ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
Targeted Oncology11h
FDA Approves Revumenib in KMT2A-Rearranged Acute Leukemia
Revumenib is now an FDA-approved treatment for adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute ...
Eli Lilly's weight-loss drug helps nearly 99% of patients remain diabetes-free
Eli Lilly said on Wednesday its weight-loss drug helped nearly 99% of patients remain diabetes-free after three years of ...
STAT1d
Facing a dialogue with RFK Jr., a top FDA official mounts a public defense of vaccines
Facing with a dialogue with RFK Jr., a top FDA official mounts a public defense of vaccines — and pleads for open minds.
AI in clinical trials presents a data-driven model
Clinical trials are a significant part of the drug development cycle. However, the process has remained unchanged in recent ...
STAT3d
A scrap of data on Amgen’s obesity drug candidate wipes out $12 billion in market value
On Tuesday, a tiny shred of data on Amgen’s lead obesity candidate — not yet verified — erased $12 billion in market value.
These Cold and Flu Medicines Contain Phenylephrine, the Ingredient the FDA Plans to Ban
Phenylephrine is a medication that’s been used to relieve nasal congestion caused by colds, allergies, and hay fever, per the ...
FiercePharma3d
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 ...
Other voices: AI will transform medicine. But it needs more data first
A key challenge for AI-reliant medical devices is the amount of data needed to train their models. In the U.S., such ...
PTC Therapeutics wins FDA nod for gene therapy
PTC Therapeutics (PTCT) stock on watch as company receives FDA approval for gene therapy Kebilidi for AADC deficiency. Read ...
FiercePharma1d
GAO takes FDA to task over lagging plant inspections, recommends action plan
“FDA has not yet developed action plans to fully address travel, workload, and work-life balance because potential solutions ...