Ionis Pharmaceuticals’ drug became the only approved treatment to significantly lower triglyceride levels and reduce acute pancreatitis events in the condition.
Tag: FDA
Sanofi’s Tzield Receives FDA Accelerated Approval to Delay Stage 3 Type 1 Diabetes in Children
The drug received accelerated approval for use in children aged 8 to 17 with recently diagnosed stage 3 type 1 diabetes to delay disease progression.
FDA Opts Not to Regulate Wearable Blood Pressure Device as Medical Device After Labelling Revisions
A major wearable technology company revised its blood pressure feature as a general wellness tool avoiding FDA medical device classification.
FDA-Approved Drug AMD3100 May Help Immunotherapy Defeat Rare Liver Cancer by Freeing Trapped T Cells
Researchers found AMD3100 releases T cells from fibrous tissue surrounding tumors enabling immune system to attack cancer cells.
US FDA Approves Small Number of Drugs Under New Expedited Review Program
The agency granted accelerated approval to a handful of therapies under a fast-track programme that has drawn scrutiny over how rigorously it evaluates clinical evidence.
US FDA Adopts ICH M11 Guideline for International Clinical Trial Protocol Harmonization
The regulatory update published in the Federal Register aims to standardise clinical trial documentation across international borders making global studies easier to run.
FDA Approves New Sunscreen Ingredient Used Safely in Europe and Asia for Decades
The FDA granted approval for bemotrizinol, a broad-spectrum UVA/UVB blocking ingredient already widely used outside the US for 20 years.
Claim That FDA Approved Two Oncology Drugs in Record Time Found to Be Misleading
Fact checkers found that viral claims about the FDA approving two new cancer drugs in record time were misleading omitting key context about conditional accelerated approvals.
RFK Jr Overstated Impact of FDA Expedited Drug Approval Programme by Making Misleading Comparisons
FactCheck.org found that the HHS Secretary made misleading claims about the speed of drug approvals under the new review programme