A primary benefit of the FDA Fast Track designation is how it accelerates the drug approval process. Early and continuous communication helps organizations identify and proactively address any ...

Four years after getting the first drug approved by the FDA to treat rare disease hereditary ATTR amyloidosis, Alnylam has got the go-ahead for a second – Amvuttra – which has a simpler ...

After months of uncertainty and controversy, the FDA has given approval to Sarepta's Duchenne muscular dystrophy drug – even though it hasn't yet shown any proof it can slow progress of the ...

The FDA has granted approval to revumenib for the treatment of adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute leukemia. 1 Data from the phase 1/2 AUGMENT-101 trial, as ...

In today's demanding world, achieving optimal health and maintaining peak performance is more crucial than ever. Many ...

The new findings showed improvements in HbA1c, hypoglycemia, body weight, and systolic blood pressure with sotagliflozin in this patient population, though the risk of diabetic ketoacidosis continues ...

Researchers wishing to appeal against the decision of one of the Research Ethics Panels (REP) should, in the first instance, appeal the decision with the Chair of the REP. The Chair will review the ...

(AP Photo/Steven Senne, File) Updated [hour]:[minute] [AMPM] [timezone], [monthFull] [day], [year] A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few ...

Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA granted full approval to the menin inhibitor revumenib (Revuforj) for adults and children 1 year and older with ...

Despite the FDA's decision, Oclavia remains available for treating appropriate PBC patients in the U.S under its current accelerated approval status. Intercept plans to work with the FDA on ...

Effective treatments for myelin repair are currently lacking. Here, the authors show that two FDA-approved drugs, leucovorin and dyclonine, identified through pharmacogenomic screening ...

A groundbreaking medication designed to delay the onset of Alzheimer's has received approval for use within the EU. The drug, which is given via an intravenous drip every two weeks, has been ...