The FDA approved linaclotide (Linzess) capsules to treat irritable bowel syndrome with constipation (IBS-C) in children age 7 ...

The FDA has approved Transcranial Magnetic Stimulation (TMS), a non-drug, magnetic pulse device, for use in teens as young as ...

FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, while safe, ...

The FDA warning letters mostly went to cosmetic websites. In each case, the FDA said the companies were offering unofficial ...

The first botulinum toxin product, onabotulinumtoxinA, was approved by the FDA in 1989. Since then, FDA has approved several ...

The FDA has approved Kygevvi (doxecitine and doxribtimine) for the treatment of TK2d in adults and pediatric patients with an age of symptom onset on or before 12 years.

The FDA plans to eliminate comparative clinical study requirements that currently add $24 million and up to eight years to ...

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Biohaven regarding the New Drug Application (NDA) for troriluzole for the treatment of adults with spinocerebellar ...

Treatments for asthma, chronic rhinosinusitis with nasal polyps, dyslipidemia, Cushing syndrome, gonorrhea, HSCT-associated thrombotic microangiopathy, marginal zone lymphoma, motion sickness, ...

It is fair to say (no matter what else can be said) that the current administration is outcome- rather than process-driven. This general ...

After a three-month delay, the FDA has now rejected an approval request based on the RWE. According to Biohaven, the FDA’s complete response letter “cited issues that can be inherent to real-world ...

The agency might dissuade patients from participating in a crucial part of our research-and-development system.